Lo Minastrin Fe

Product NDC
0430-0537
11-digit product format
004300537
Labeler code
0430
Product ID
0430-0537_42485d4a-92b9-4de6-9bfb-acd959e71fda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate
Dosage form
KIT
Labeler
Allergan, Inc.
Application
NDA204654
Marketing category
NDA
Marketing start
2013-08-12
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0430-0537DDiscontinued by firm2026-08-17
excluded packagepackage0430-05370430-0537-50DDiscontinued by firm2026-08-17
excluded packagepackage0430-05370430-0537-95DDiscontinued by firm2026-08-17

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 · 36 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0430-0537-95d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0430-0537-50d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0430-0537-95f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0430-0537-50f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0430-0537-952ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0430-0537-502ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0430-0537-95a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0430-0537-50a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0430-0537-95cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0430-0537-50cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0430-0537-95cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0430-0537-50cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0430-0537-95302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0430-0537-50302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0430-0537-95ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0430-0537-50ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0430-0537-950efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0430-0537-500efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0430-0537-95ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0430-0537-50ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0430-0537-95367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0430-0537-50367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0430-0537-95557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0430-0537-50557ba5c1ecfa…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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N204654-001LO MINASTRIN FEETHINYL ESTRADIOL; NORETHINDRONE ACETATE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24

Orange Book patents#

Current patent rows page 1 of 1 · 1 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N204654-00177049842029-02-02U-1

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-2487673890dc5c…
2021-03-12 10:30 UTC2021-03N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-245aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-248869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-243f01610625f2…
2019-09-15 20:21 UTC2019-09N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24b00525d2431f…
2019-07-19 19:46 UTC2019-07N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-246a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-241c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-249b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-243f0d92c62455…
2023-05-13 08:27 UTC2023-05N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24053a50430f4f…
2023-01-26 05:58 UTC2023-01N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-243bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-243a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N204654-001LO MINASTRIN FE0.01MG,0.01MG,N/A;1MG,N/A,N/ATABLET, CHEWABLE, TABLET / ORALRLD2013-07-24e64feba35796…

Observed Orange Book patent history#

Patent history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N204654-00177049842029-02-02U-1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N204654-00177049842029-02-02U-1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N204654-00177049842029-02-02U-131067a03dcf5…
2025-08-23 18:47 UTC2025-08N204654-00177049842029-02-02U-16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N204654-00177049842029-02-02U-1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N204654-00177049842029-02-02U-1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N204654-00177049842029-02-02U-103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N204654-00177049842029-02-02U-12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N204654-00177049842029-02-02U-15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N204654-00177049842029-02-02U-1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N204654-00177049842029-02-02U-1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N204654-00177049842029-02-02U-179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N204654-00177049842029-02-02U-1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N204654-00177049842029-02-02U-11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N204654-00177049842029-02-02U-18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N204654-00177049842029-02-02U-15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N204654-00177049842029-02-02U-15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N204654-00177049842029-02-02U-14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N204654-00166670502019-04-06U-1Drug product2013-08-0274a2ff9319b5…
2019-12-13 00:20 UTC2019-12N204654-00177049842029-02-02U-174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N204654-00177049842029-02-02U-1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N204654-00177049842029-02-02U-1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N204654-00177049842029-02-02U-187673890dc5c…
2021-03-12 10:30 UTC2021-03N204654-00177049842029-02-02U-15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N204654-00177049842029-02-02U-18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N204654-00177049842029-02-02U-1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N204654-00166670502019-04-06U-1Drug product2013-08-023f01610625f2…
2019-12-14 00:12 UTC2019-12N204654-00177049842029-02-02U-13f01610625f2…
2019-09-15 20:21 UTC2019-09N204654-00166670502019-04-06U-1Drug product2013-08-02b00525d2431f…
2019-09-15 20:21 UTC2019-09N204654-00177049842029-02-02U-1b00525d2431f…
2019-07-19 19:46 UTC2019-07N204654-00166670502019-04-06U-1Drug product2013-08-02ea99ee380514…
2019-07-19 19:46 UTC2019-07N204654-00177049842029-02-02U-1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N204654-00177049842029-02-02U-16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N204654-00177049842029-02-02U-11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N204654-00177049842029-02-02U-1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N204654-00177049842029-02-02U-1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N204654-00177049842029-02-02U-19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N204654-00177049842029-02-02U-1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N204654-00177049842029-02-02U-13f0d92c62455…
2023-05-13 08:27 UTC2023-05N204654-00177049842029-02-02U-1053a50430f4f…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0430-0537-14EA - Each0430-053712f38f2b-cd53-482e-bf13-73b8a63db15e12013-09-04
0430-0537-50EA - Each0430-053796e1ca5e-a78b-49f9-8f8a-be8e4d7b3f8a12013-09-04