Home NDC 0378-7291-89 Norethindrone Acetate
Product NDC 0378-7291
Requested package NDC 0378-7291-89
11-digit product format 003787291
Labeler code 0378
Product ID 0378-7291_7480bf8e-3dcd-4697-9f0f-924beb419ee9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate
Dosage form TABLET
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application ANDA205278
Marketing category ANDA
Marketing start 2019-07-19
Marketing end 0000-00-00
Substance NORETHINDRONE ACETATE
Active strength 5 mg/1
Pharmacologic classes Progesterone Congeners [CS],Progestin [EPC]
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0378-7291 0378-7291-89 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
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 A205278-001 NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205278-001 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 · 41 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 2026-02-19 14:30 UTC 2026-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0378-7291 NORETHINDRONE ACETATE TABLET [MYLAN PHARMACEUTICALS INC.] 5 Legacy NDC 20250221_4e8e531a-dac2-44ce-b06b-390296c26833.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 0378-7291-89 00378729189 50 TABLET in 1 BOTTLE (0378-7291-89) 50 tablet 2019-07-19 0000-00-00 No No Current