1. APIs
  2. Levonorgestrel
  3. US FDA-Approved Products

Levonorgestrel US FDA-Approved Products

Name Formulation Status ANDA #
Lo/Ovral FE Prescription 018206
Vienva ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 oral tablets Prescription 201088
Simpesse ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, N/A Oral tablet Prescription 206851
Setlakin ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 090716
Opcicon One-Step LEVONORGESTREL: 1.5 mg Oral tablet Over-the-counter 202635
Lo Simpesse ETHINYL ESTRADIOL: 0.02 mg, 0.01 mg LEVONORGESTREL: 0.01 mg, N/A Oral tablet Prescription 206852
Liletta LEVONORGESTREL: 52 mg Intrauterine device Prescription NDA# 206229
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol, #200493 ETHINYL ESTRADIOL: 0.02 mg, 0.01 mg LEVONORGESTREL: 0.1 mg, N/A Oral tablet Prescription 200493
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol, #200492 ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, N/A Oral tablet Prescription 200492
Levonorgestrel and Ethinyl Estradiol and Ethinyl Estradiol, #078834 ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, N/A Oral tablet Prescription 078834
Levonorgestrel and Ethinyl Estradiol, #203872 ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, N/A Oral tablet Prescription 203872
Levonorgestrel and Ethinyl Estradiol, #203871 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 203871
Levonorgestrel and Ethinyl Estradiol, #203164 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 203164
Levonorgestrel and Ethinyl Estradiol, #202791 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.09 mg Oral tablet Prescription 202791
Levonorgestrel and Ethinyl Estradiol, #202247 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 oral tablets Prescription 202247
Levonorgestrel and Ethinyl Estradiol, #201108 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 oral tablets Prescription 201108
Levonorgestrel and Ethinyl Estradiol, #201095 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 oral tablets Prescription 201095
Levonorgestrel and Ethinyl Estradiol, #200490 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablets Prescription 200490
Levonorgestrel and Ethinyl Estradiol, #200407 ETHINYL ESTRADIOL: 0.02 mg, 0.01 mg LEVONORGESTREL: 0.1 mg, N/A Oral tablets Prescription 200407
Levonorgestrel, #207044 LEVONORGESTREL: 1.5 mg Oral tablet Over-the-counter 207044
Levonorgestrel, #202740 LEVONORGESTREL: 0.75 mg Oral tablet Prescription; Over-the-counter 202740
Levonorgestrel, #202739 LEVONORGESTREL 1.5 mg Oral tablet Over-the-counter 202739
Levonorgestrel, #202684 LEVONORGESTREL 0.75 mg Oral tablet Prescription; Over-the-counter 202684
Levonorgestrel, #202380 LEVONORGESTREL 1.5 mg Oral tablet Over-the-counter 202380
Levonorgestrel, #202334 LEVONORGESTREL 1.5 mg Oral tablet Over-the-counter 202334
Levonorgestrel, #090740 LEVONORGESTREL 0.75 mg Oral tablet Prescription; Over-the-counter 090740
Levonorgestrel, #202246 LEVONORGESTREL 1.5 mg Oral tablet Over-the-counter 202246
Kyleena Intrauterine Device LEVONORGESTREL: 19.5 mg Prescription 208224
Jadelle Implant LEVONORGESTREL: 75 mg Discontinued 020544
Fayosim ETHINYL ESTRADIOL: 0.02 mg, 0.025 mg, 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, 0.15 mg, 0.15 mg, NA Oral tablet Prescription 205943
Fallback Solo LEVONORGESTREL: 1.5 mg Oral tablet Over-the-counter 201446
Ethinyl Estradiol and Levonorgestrel ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15mg, NA Oral tablet None (Tentative Approval) 091690
Elifemme ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg Oral tablet Prescription 202507
Ayuna ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 206866
Athentia Next LEVONORGESTREL: 1.5 mg Oral tablet Over-the-counter 206867
Ashlyna ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablets Prescription 203163
Afirmelle ETHINYL ESTRADIOL: 0.02 mg; LEVONORGESTREL 0.1 mg oral tablet. Prescription 206886
Climara Pro ESTRADIOL: 0.045 mg/day LEVONORGESTREL 0.015 mg/day Film, Extended Release, Transdermal; Apply once-weekly to lower abdomen Each 22 cm^2 system contains 4.4 mg estradiol and 1.39 mg levonorgestrel. System comprises three layers: (1) a translucent polyethylene backing film (2) an acrylate adhesive matrix containing estradiol and levonorgestrel (acrylate copolymer adhesive and polyvinylpyrrolidone/vinylacetate copolymer) (3) A protective layer of either siliconized or fluoropolymer coated polyester film. The protective liner is attached to the adhesive surface and must be removed before the system can be used. Prescription 021258 (Bayer), 021885 (Berlex)
Aviane-28 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.10 mg 28 oral tablets Inactive ingredients: FD&C Yellow No. 6, Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, preglatinized starch, sodium starch glycolate and titanium dioxide Prescription 075796
Aviane-21 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.10 mg 21 oral tablets Inactive ingredients: FD&C Yellow No. 6, Aluminum Lake, hydroxypropyl methylcellulose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, preglatinized starch, sodium starch glycolate and titanium dioxide Discontinued 075796
Falmina ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 oral tablets Prescription 090721
Enpresse-28 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 28 oral tablets Prescription 075809
Enpresse-21 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 21 oral tablets Discontinued 075809
Daysee ETHINYL ESTRADIOL: 0.03, 0.01 mg LEVONORGESTREL: 0.15 mg, NA Oral tablet Prescription 091467
Altavera ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 oral tablets Prescription 079102
Introvale ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 079064
Kurvelo ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Prescription 091408
Lessina-21 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 21 Oral tablets Discontinued 075803
Lessina-28 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 Oral tablets Prescription 075803
Levlite ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 21 or 28 Oral tablets Discontinued 020860
Levonest ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 28 Oral tablets Prescription 090719
Levonorgestrel, #020627 Levonorgestrel: 75 mg Implant Discontinued NDA #020627
Levonorgestrel, #078665 Levonorgestrel: 0.75 mg Oral tablet Discontinued 078665
Levonorgestrel, #078666 Levonorgestrel: 0.75 mg Oral tablet Discontinued 078666
Levonorgestrel, #091328 Levonorgestrel 0.75 mg Oral tablet Over-the-counter; Discontinued 091328
Levonorgestrel, #200670 Levonorgestrel: 1.5 mg Oral tablet Over-the-counter 200670
Levonorgestrel, #202508 Levonorgestrel (1.5 mg) Oral tablet Over-the-counter 202508
Levonorgestrel and Ethinyl Estradiol, #075862 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 21 or 28 oral tablets Discontinued 075862
Levonorgestrel and Ethinyl Estradiol, #076625 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.10 mg 28 oral tablets. Inactive ingredients: croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose and povidone. 7 inactive tablets: FD&C Yellow #6, lactose anhydrous, magnesium stearate, and microcrystalline cellulose. Prescription 076625
Levonorgestrel and Ethinyl Estradiol, #077681 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 Oral tablets Prescription 077681
Levonorgestrel and Ethinyl Estradiol, #079218 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.09 mg Oral tablet Prescription 079218
Levonorgestrel and Ethinyl Estradiol, #091425 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 Oral tablets Prescription 091425
Levonorgestrel and Ethinyl Estradiol, #091440 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 091440
Levonorgestrel and Ethinyl Estradiol, #091663 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Prescription 091663
Levonorgestrel and Ethinyl Estradiol, #091674 ETHINYL ESTRADIOL: 0.02 mg, 0.01 mg LEVONORGESTREL: 0.1 mg, N/A Oral tablet Prescription 091674
Levonorgestrel and Ethinyl Estradiol, #200245 ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 Oral tablets Prescription 200245
Levonorgestrel and Ethinyl Estradiol, #200407 ETHINYL ESTRADIOL: 0.02 mg, 0.01 mg LEVONORGESTREL: 0.1 mg, N/A Oral tablet Prescription 200407
Levora 0.15/30-21 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Discontinued 073592
Levora 0.15/30-28 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Prescription 073594
Loseasonique ETHINYL ESTRADIOL; LEVONORGESTREL. 84 tablets containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol, inactive ingredients = FD&C Yellow #6 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, corn starch, titanium dioxide and triacetin; 7 tablets containing 0.01 mg ethinyl estradiol, inactive ingredients: anhydrous lactose, FD&C Yellow #10 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide Prescription
Lybrel ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.09 mg 28 oral tablets Inactive ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, polacrilin potassium, hypromellose, titanium dioxide, polyethylene glycol 400, iron oxide, polyethylene glycol 1450, montanic ester wax Discontinued 021864
Marlissa ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Prescription 091452
MIRENA LEVONORGESTREL (52 mg). Intrauterine device consisting of a T-shaped polyethylene frame with a steroid reservoir containing 52 mg levonorgestrel packaged within a sterile inserter. The reservoir consists of a white cylinder made of a mixture of levonorgestrel and silicone (polydimethylsiloxane) membrane. The T-body is 32 mm in both the horizontal and vertical directions. The polyethylene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread it attached to a loop at the end of the vertical stem of the T-body. Prescription
Myzilra ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 28 Oral tablets Prescription 077502
Nordette-21 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 21 Oral tablets Discontinued 018668
Nordette-28 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 Oral tablets Discontinued 018782
NORPLANT LEVONORGESTREL (36 mg). Implant (36 mg). Discontinued
NORPLANT II LEVONORGESTREL (75 mg). Implant (36 mg). Discontinued
NORPLANT SYSTEM IN PLASTIC CONTAINER LEVONORGESTREL (36 mg). Implant (36 mg). Discontinued
Orsythia ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.1 mg 28 oral tablets Prescription 077099
PLAN B LEVONORGESTREL (0.75 mg). Oral Tablets. Inactive ingredients: colloidal silicon dioxide, potato starch, gelatin, magnesium stearate, talc, corn starch, lactose monohydrate. Prescription and Over-the-Counter
PLAN B ONE-STEP LEVONORGESTREL (1.5 mg). Oral Tablets. Inactive ingredients: colloidal silicon dioxide, corn starch, lactose monohydrate, magnesium stearate, potato starch, talc. Over-the-Counter
Portia-21 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 21 oral tablets Discontinued 075866
Portia-28 ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 28 oral tablets Prescription 075866
Quartette ETHINYL ESTRADIOL: 0.2 mg, 0.025 mg, 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, 0.15 mg, 0.15 mg, N/A 91 Oral Tablets: 42 tablets containing 0.15 mg levonorgestrel and 0.02 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C Blue no 2./Indigo Carmine aluminum lake, FD&C yellow no. 6/sunset yellow FCF aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol, macrogol, titanium dioxide, triacetin); 21 tablets containing 0.15 mg levonorgestrel and 0.025 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C blue no. 2/indigo carmine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide and triacetin); 21 tablets containing 0.15 mg levonorgestral and 0.02 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C Red no. 27/phloxine aluminum lake, FD&C blue no. 1/brilliant blue FCF aluminum lake, hypromellose, D&C red no. 27/phloxine aluminum lake, hypromellose, lactose monohydrate, microcrystalline cellulose, magnesium stearate, polyethylene glycol/macrogol, titanium dioxide, triacetin); 7 tablets containing 0.01 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6/sunset yellow FCF aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol/macrogol, polysorbate 80 and titanium dioxide) Prescription 204061
Preven Emergency Contraceptive Kit ETHINYL ESTRADIOL: 0.05 mg LEVONORGESTREL: 0.25 mg Oral tablet Inactive ingredients: polacrilin potassium, lactose, magnesium stearate, hydroxypropyl methylcellulose, titanium dioxide, polyethylene glycol, polysorbate 80 and FD & C Blue No.2 Aluminum Lake Discontinued 020946
Quasense ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg Oral tablet Prescription 077101
Seasonale ETHINYL ESTRADIOL: 0.03 mg LEVONORGESTREL: 0.15 mg 91 Oral Tablets: 84 Active Tablets: Inactive ingredients = anhydrous lactose NF, FD&C blue no. 1, FD&C red no. 40, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, polyethylene glycol NF, magnesium stearate NF, polysorbate 80 NF, and titanium dioxide USP. 7 Insert Tablets: Inactive ingredients – anhydrous lactose NF, hydroxypropyl methylcellulose USP, microcrystalline cellulose NF, and magnesium stearate NF Prescription 021544
Seasonique ETHINYL ESTRADIOL: 0.03 mg, 0.01 mg LEVONORGESTREL: 0.15 mg, N/A 91 tablets: 84 tablets containing 0.15 mg levonorgestrel and 0.03 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C yellow no. 10 aluminum lake, FD&C blue no. 1 aluminum lake, FD&C yellow no. 6/sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, titanium dioxide, triacetin. 7 tablets containing 0.01 mg ethinyl estradiol (inactive ingredients = anhydrous lactose, D&C yellow. 10 aluminum lake, FD&C blue no. 10 aluminum lake, FD&C yellow no. 6/sunset yellow aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacrilin potassium, polyethylene glycol, polysorbate 80 and titanium dioxide) Prescription 021840
SKYLA LEVONORGESTREL (13.5 mg). Intrauterine Device; sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 13.5 mg levonorgestrel packaged within a sterile inserter. Release rate = 14 μg/day after 24 days and declines to 5 μg/day after 3 years. Reservoir is a mixture of levonorgestrel and silicone (PDMS) and is covered by a semi-opaque silicone membrane, composed of PDMS and colloidal silica. A ring composed of 99.95% pure silver is located at the top of the vertical stem close to the horizontal arms and is visible by ultrasound. The polyethyelene of the T-body is compounded with barium sulfate, which makes it radiopaque. A monofilament brown polyethylene removal thread (colored with iron oxide) is attached to a loop at the end of the vertical stem of the T-body. Prescription
Triphasil-21 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 21 oral tablets Discontinued 019192
Triphasil-28 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 28 oral tablets Discontinued 019190
Trivora-21 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 21 oral tablets Discontinued 074538
Trivora-28 ETHINYL ESTRADIOL: 0.03 mg, 0.04 mg, 0.03 mg LEVONORGESTREL: 0.05 mg, 0.075 mg, 0.125 mg 28 oral tablets Prescription 074538
Alesse ETHINYL ESTRADIOL: 0.02 mg LEVONORGESTREL: 0.10 mg 21 or 28 oral tablets. Inactive Ingredients: cellulose, hypromellose, iron oxide, lactose, magnesium stearate, polacrilin, potassium, polyethylene glycol, titanium dioxide and montanic ester wax 7 inactive tablets: FD&C blue no. 1, hypromollose, iron oxide, lactose, magnesium stearate, polacrilin potassium, polyethylene glycol, titanium dioxide and montanic ester wax. Discontinued 020683