Home NDC 52544-058-72 Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Product NDC 52544-058
Requested package NDC 52544-058-72
11-digit product format 525440058
Labeler code 52544
Product ID 52544-058_f49b166c-00c1-46bf-b6f1-206df1ae29ce
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol and Ferrous Fumarate
Dosage form KIT
Labeler Actavis Pharma, Inc.
Application NDA203667
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2017-03-16
Marketing end 2023-04-30
Active strength 0
NDC exclude flag No
Listing certified through 0000-00-00
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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
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 N203667-001 MINASTRIN 24 FE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08
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 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N203667-001 MINASTRIN 24 FE 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2013-05-08 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET, CHEWABLE / ORAL AB RLD, RS 2013-05-08 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL RLD 2013-05-08 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N203667-001 MINASTRIN 24 FE 0.02MG;1MG TABLET / ORAL AB RLD, RS 2013-05-08 e64feba35796…
Observed Orange Book normalized TE history# Observed Orange Book patent history# Captured, Edition, Application-product table Captured Edition Application-product Patent Expiration Use code Coverage / status Submission date Source SHA-256 2019-12-13 00:20 UTC 2019-12 N203667-001 6667050 2019-04-06 U-1 Drug product 2014-04-17 74a2ff9319b5…2019-12-14 00:12 UTC 2019-12 N203667-001 6667050 2019-04-06 U-1 Drug product 2014-04-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N203667-001 6667050 2019-04-06 U-1 Drug product 2014-04-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N203667-001 6667050 2019-04-06 U-1 Drug product 2014-04-17 ea99ee380514…
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52544-058-72 52544005872 5 POUCH in 1 CARTON (52544-058-72) > 1 BLISTER PACK in 1 POUCH (52544-058-41) > 1 KIT in 1 BLISTER PACK 5 pouch 2017-03-16 2023-04-30 No No Current