Home NDC 0378-7274 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Product NDC 0378-7274
11-digit product format 003787274
Labeler code 0378
Product ID 0378-7274_8a7faa9f-224f-fb2e-fde2-986d2142dc2f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA202770
Marketing category ANDA
Marketing start 2019-09-25
Substance ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
Active strength .03; 1.5 mg/1; mg/1
Pharmacologic classes Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A202770-001 AB
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 2 · 42 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 2026-08-18 06:07:40 2026-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A202770-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 0.03MG;1.5MG TABLET / ORAL-21 AB 2015-02-19 e64feba35796…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 observed states.
Additional Listing Data#
Finished product Yes
Brand name base NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETHINYL ESTRADIOL .03 mg/1 NORETHINDRONE ACETATE 1.5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 423D2T571U Internal UNII lookup 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1359022 Internal RxNorm lookup 1359028 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0378-7274-53 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 3 in 1 CARTON TABLET 3 6 0378-7274-85 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 1 in 1 POUCH TABLET 1 6 0378-7274-85 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL 21 in 1 BLISTER PACK TABLET 21 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-7274 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL TABLET [MYLAN PHARMACEUTICALS INC.] 5 Current NDC, Legacy NDC, 3 package rows 20250221_3108a9bc-3378-459d-8f6b-bd5eff2ad657.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-7274-53 00378727453 3 POUCH in 1 CARTON (0378-7274-53) / 1 BLISTER PACK in 1 POUCH (0378-7274-85) / 21 TABLET in 1 BLISTER PACK 3 pouch 2019-09-25 0000-00-00 No No Current 0378-7274-85 00378727485 1 in 1 POUCH Historical