Home NDC 0378-7295-53 ESTRADIOL AND NORETHINDRONE ACETATE
Product NDC 0378-7295
Requested package NDC 0378-7295-53
11-digit product format 003787295
Labeler code 0378
Product ID 0378-7295_b24d133a-50ee-4fd6-926d-cac8f34e8ebd
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name estradiol and norethindrone acetate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA207261
Marketing category ANDA
Marketing start 2018-07-24
Marketing end 0000-00-00
Substance ESTRADIOL; NORETHINDRONE ACETATE
Active strength 1 mg/1; mg/1
Pharmacologic classes Estradiol Congeners [CS],Estrogen [EPC],Estrogen Receptor Agonists [MoA],Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE ESTRADIOL; NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 3 · 86 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 84e616aacf4f…2026-09-14 22:38:34 2026-08 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207261-001 ESTRADIOL AND NORETHINDRONE ACETATE 0.5MG;0.1MG TABLET / ORAL AB 2017-02-10 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 A207261-002 ESTRADIOL AND NORETHINDRONE ACETATE 1MG;0.5MG TABLET / ORAL AB 2017-02-10 74a2ff9319b5…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 86 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-7295 ESTRADIOL AND NORETHINDRONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.] 9 Legacy NDC 20250216_6cafe148-bfb8-4c09-a056-b0637c0c3065.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ABIGALE LO ESTRADIOL AND NORETHINDRONE ACETATE Xiromed LLC df013d36-de10-0607-7e12-95ed43bf7ee9 2024-09-17 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 207261 application number: ANDA207261
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-7295-53 00378729553 3 POUCH in 1 CARTON (0378-7295-53) > 1 BLISTER PACK in 1 POUCH (0378-7295-85) > 28 TABLET in 1 BLISTER PACK 3 pouch 2018-07-24 0000-00-00 No No Current