Norethindrone Acetate US FDA-Approved Products

Name Formulation Status ANDA #
Hailey FE 1/20 Prescription 206597
Aurovela FE 1/20 Prescription 207505
Aurovela FE 1.5/30 Prescription 207580
Aurovela 1/20 Prescription 207506
Aurovela 1.5/30 Prescription 207581
Aurovela 24 FE Prescription 207504
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate, #204847 Prescription 204847
Gildess 24 FE ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 090293
Gildess 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Prescription 077077
Gildess FE 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 oral tablets
Prescription 077075
Tri-Legest 21 ETHINYL ESTRADIOL: 0.02 mg, 0.03 mg, 0.035 mg
NORETHINDRONE ACETATE: 1 mg, 1 mg, 1 mg
21 oral tablets
Prescription 076405
Taytulla ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 204426
Norlutate NORETHINDRONE ACETATE: 5 mg
Oral tablet
Discontinued 012184
Norlestrin FE 2.5/50 ETHINYL ESTRADIOL: 0.05 mg
NORETHINDRONE ACETATE: 2.5 mg
FERROUS FUMARATE: 75 mg
28 oral tablets
Discontinued 016854
Norlestrin FE 1/50 ETHINYL ESTRADIOL: 0.05 mg
NORETHINDRONE ACETATE: 1 mg
FERROUS FUMARATE: 75
28 oral tablets
Discontinued 016766
Norlestrin 28 1/50 ETHINYL ESTRADIOL: 0.05 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Discontinued 016723
Norlestrin 21 2.5/50 ETHINYL ESTRADIOL: 0.05 mg
NORETHINDRONE ACETATE: 2.5 mg
21 oral tablets
Discontinued 016852
Norlestrin 21 1/50 ETHINYL ESTRADIOL: 0.05 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Discontinued 016749
Norethindrone Acetate; Ethinyl Estradiol; Ethinyl Estradiol; Ferrous Fumarate NORETHINDRONE ACETATE; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; FERROUS FUMARATE: 75 mg
Oral tablet
None (Tentative Approval) 208097
Norethindrone Acetate Ethinyl Estradiol; Ferrous Fumarate NORETHINDRONE ACETATE ETHINYL ESTRADIOL: 1 mg
FERROUS FUMARATE: 0.02 mg
[This is possibly meant to say 0.02 mg Ethinyl Estradiol, 1 mg Norethindrone Acetate]
Oral tablet
None (Tentative Approval) 207514
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate, #202742 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 202742
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate, #090938 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 090938
Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate, #078267 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 078267
Norethindrone Acetate and Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate ETHINYL ESTRADIOL: 0.01 mg, 0.01 mg
NORETHINDRONE ACETATE: 1 mg, N/A
Oral tablet
Prescription 205049
Norethindrone Acetate and Ethinyl Estradiol, #207260 ETHINYL ESTRADIOL: 0.0025 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet
Prescription 207260
Norethindrone Acetate and Ethinyl Estradiol, #207259 ETHINYL ESTRADIOL: 0.005 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 207259
Norethindrone Acetate and Ethinyl Estradiol, #206969 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Prescription 206969
Norethindrone Acetate and Ethinyl Estradiol, #206120 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Chewable tablet
None (Tentative Approval) 206120
Norethindrone Acetate and Ethinyl Estradiol, #203038 ETHINYL ESTRADIOL: 0.0025 mg, 0.005 mg
NORETHINDRONE ACETATE: 0.5 mg, 1 mg
Oral tablet
Prescription 203038
Norethindrone Acetate and Ethinyl Estradiol, #202772 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 oral tablets
Prescription 202772
Norethindrone Acetate and Ethinyl Estradiol, #202771 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Prescription 202771
Norethindrone Acetate and Ethinyl Estradiol, #202770 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 oral tablets
Prescription 202770
Norethindrone Acetate and Ethinyl Estradiol, #202741 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 oral tablets
Prescription 202741
Norethindrone Acetate and Ethinyl Estradiol, #076629 ETHINYL ESTRADIOL: 0.02 mg, 0.03 mg, 0.035 mg
NORETHINDRONE ACETATE: 1 mg, 1 mg, 1 mg
28 oral tablets
Prescription 076629
Norethindrone Acetate and Ethinyl Estradiol, #076221 ETHINYL ESTRADIOL: 0.005 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 076221
Norethindrone Acetate, #205278 NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 205278
Norethindrone Acetate, #204236 NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 204236
Norethindrone Acetate, #200275 NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 200275
Norethindrone Acetate, #091090 NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 091090
Norethindrone Acetate, #075951 NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 075951
Norethin 1/50M-28 MESTRANOL: 0.05 mg
NORETHINDRONE ACETATE: 1 mg
28 oral tablets
Discontinued 071540
Norethin 1/50M-21 MESTRANOL: 0.05 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Discontinued 071539
Nexesta FE ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 0.4 mg
Chewable tablet
Prescription 207535
N.E.E. 1/35 28 ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 1 mg
28 oral tablets
Discontinued 071542
N.E.E. 1/35 21 ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Discontinued 071541
Modicon 28 ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 0.5 mg
28 oral tablets
Prescription 017735
Modicon 21 ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 0.5 mg
21 oral tablets
Discontinued 017488
Minastrin 24 FE ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Chewable tablets
Prescription 203667
Microgestin FE 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 oral tablets
Prescription 075647
Microgestin FE 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 oral tablets
Prescription 075548
Microgestin 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Prescription 075647
Microgestin 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 oral tablets
28 oral tablets
Prescription 075548
Mibelas 24 FE ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Chewable tablets
Prescription 206287
Lupaneta Pack LEUPROLIDE ACETATE: 2.75 mg/vial, N/A, 11.25 mg/vial, N/A
NORETHINDRONE ACETATE: N/A, 5 mg, N/A, 5 mg
Injectable Oral tablet
Prescription 203696
Loestrin FE 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 oral tablets
Prescription 017354
Loestrin FE 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 oral tablets
Prescription 017355
Loestrin 24 FE ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 021871
Loestrin 21 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 oral tablets
Prescription 017876
Loestrin 21 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 oral tablets
Prescription 017875
Lo-Blisovi FE ETHINYL ESTRADIOL: 0.01 mg
NORETHINDRONE ACETATE: 1 mg
FERROUS FUMARATE: 75 mg
Oral tablet
None (Tentative Approval) 203113
Lo Minastrin FE ETHINYL ESTRADIOL: 0.01 mg, 0.01 mg, N/A
NORETHINDRONE ACETATE: 1 mg, N/A, N/A
Chewable tablet
Prescription 204654
Lo Loestrin FE ETHINYL ESTRADIOL: 0.01 mg, 0.01 mg
NORETHINDRONE ACETATE: 1 mg, N/A
Oral tablet

ETHINYL ESTRADIOL: 10 mcg
Oral tablet

FERROUS FUMARATE: 75 mg
Oral tablet
Prescription 022501
Lo Larin FE ETHINYL ESTRADIOL: 0.01 mg, 0.01 mg
NORETHINDRONE ACETATE: 1 mg, N/A
Oral tablet

ETHINYL ESTRADIOL: 10 mcg
Oral tablet
None (Tentative Approval) 208661
Leribane ETHINYL ESTRADIOL: 0.005 mg, 0.0025 mg
NORETHINDRONE ACETATE: 1 mg, 0.5 mg
28 oral tablets
Prescription 203435
Larin FE 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 Oral tablets
Prescription 091454
Larin FE 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 Oral tablets
Prescription 091453
Larin 24 FE ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription 202994
Larin 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 Oral tablets
Prescription 202995
Larin 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 Oral tablets
Prescription 202996
Kaitlib FE ETHINYL ESTRADIOL: 0.025 mg
NORETHINDRONE ACETATE: 0.8 mg
Chewable tablet
Prescription 203448
Junel FE 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 Oral tablets
Prescription 076081
Junel FE 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
28 Oral tablets
Prescription 076064
Junel 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
21 Oral tablets
Prescription 076380
Junel 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 Oral tablets
Prescription 076381
Gildess FE 1/20 ETHINYL ESTRADIOL: 0.02 mg
NORETHINDRONE ACETATE: 1 mg
28 Oral tablets
Prescription 077077
Gildess 1.5/30 ETHINYL ESTRADIOL: 0.03 mg
NORETHINDRONE ACETATE: 1.5 mg
21 Oral tablets
Prescription 077075
Gidalgia ETHINYL ESTRADIOL: 0.035 mg
NORETHINDRONE ACETATE: 0.4 mg
28 Oral tablets
Prescription 078376
Gencept 10/11-28 ETHINYL ESTRADIOL: 0.035 mg, 0.035 mg
NORETHINDRONE ACETATE: 0.5 mg, 1 mg
28 Oral tablets
Discontinued 072697
Gencept 10/11-21 ETHINYL ESTRADIOL: 0.035 mg, 0.035 mg
NORETHINDRONE ACETATE: 0.5 mg, 1 mg
21 Oral tablets
Discontinued 072694
Fyavolv ETHINYL ESTRADIOL: 0.0025 mg, 0.005 mg
NORETHINDRONE ACETATE: 0.5 mg, 1 mg
Oral tablet
Prescription 204213
FemHRT, #021102 ETHINYL ESTRADIOL
NORETHINDRONE ACETATE
Oral tablet
Prescription 021102
FemHRT, #021065 Prescription:
ETHINYL ESTRADIOL: 0.0025 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet

Discontinued:
ETHINYL ESTRADIOL: 0.005 mg
NORETHINDRONE ACETATE: 1 mg
Oral tablet
Prescription; Discontinued 021065
Estrostep FE ETHINYL ESTRADIOL: 0.02 mg, 0.03 mg, 0.035 mg
NORETHINDRONE ACETATE: 1 mg, 1 mg, 1 mg
28 oral tablets
Prescription 020130
Estrostep 21 ETHINYL ESTRADIOL: 0.02 mg, 0.03 mg, 0.035 mg
NORETHINDRONE ACETATE: 1 mg, 1 mg, 1 mg
21 oral tablets
Discontinued 020130
Estradiol and Norethindrone Acetate, #207261 ESTRADIOL: 0.5 mg, 1 mg
NORETHINDRONE ACETATE: 0.1 mg, 0.5 mg
Oral tablet
Prescription 207261
Estradiol and Norethindrone Acetate, #200747 ESTRADIOL: 0.5 mg
NORETHINDRONE ACETATE: 0.1 mg
Oral tablet
Prescription 200747
Estradiol and Norethindrone Acetate, #079193 ESTRADIOL: 1 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet
Prescription 079193
Estradiol and Norethindrone Acetate, #078324 ESTRADIOL: 1 mg, 0.5 mg
NORETHINDRONE ACETATE: 0.5 mg, 0.1 mg
Oral tablet
Prescription 078324
Combipatch ESTRADIOL: 0.05 mg/24 h, 0.05 mg/24 h
NORETHINDRONE ACETATE: 0.14 mg/24 h, 0.25 mg/24h
Transdermal patch
Prescription 020870
Aygestin NORETHINDRONE ACETATE: 5 mg
Oral tablet
Prescription 018405
Amabelz ESTRADIOL: 0.5 mg, 1 mg
NORETHINDRONE ACETATE: 0.1 mg, 0.5 mg
Oral tablet
Prescription 203339
Activella (Novo Nordisk) ESTRADIOL: 1 mg
NORETHINDRONE ACETATE: 0.5 mg
Oral tablet
Prescription 021103, 022001
Activella (Amneal Pharms) ESTRADIOL: 1 mg, 0.5 mg
NORETHINDRONE ACETATE: 0.5 mg, 0.1 mg
Oral tablet
Prescription 020907