FEMCON Fe

Product NDC
0023-5970
11-digit product format
000235970
Labeler code
0023
Product ID
0023-5970_dc6841ef-48b5-41b6-b79a-ab4638faf7ca
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
norethindrone and ethinyl estradiol, and ferrous fumarate
Dosage form
KIT
Labeler
Allergan, Inc.
Application
NDA021490
Marketing category
NDA
Marketing start
2006-11-01
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0023-5970DDiscontinued by firm2026-08-17
excluded packagepackage0023-59700023-5970-05DDiscontinued 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 · 24 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 packagepackage0023-5970-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0023-5970-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0023-5970-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0023-5970-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0023-5970-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0023-5970-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0023-5970-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0023-5970-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0023-5970-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0023-5970-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0023-5970-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0023-5970-05557ba5c1ecfa…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
N021490-001FEMCON FEETHINYL ESTRADIOL; NORETHINDRONE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14

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 06:07:402026-07N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-1431067a03dcf5…
2025-08-23 18:47 UTC2025-08N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-146a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-1403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-142680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-145bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-1479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-141e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-148072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-145c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-145d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-144b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-1474a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET, CHEWABLE / ORALRLD2003-11-14bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**TABLET, CHEWABLE / ORALRLD2003-11-14782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-1487673890dc5c…
2021-03-12 10:30 UTC2021-03N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-145aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-148869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-14c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-143f01610625f2…
2019-09-15 20:21 UTC2019-09N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-14b00525d2431f…
2019-07-19 19:46 UTC2019-07N021490-001FEMCON FE0.035MG;0.4MGTABLET, CHEWABLE / ORALRLD2003-11-14ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-146a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-141c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-149b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-143f0d92c62455…
2023-05-13 08:27 UTC2023-05N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14053a50430f4f…
2023-01-26 05:58 UTC2023-01N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-143bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-143a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N021490-001FEMCON FE0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**TABLET / ORALRLD2003-11-14e64feba35796…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2019-12-13 00:20 UTC2019-12N021490-00166670502019-04-06U-1Drug product74a2ff9319b5…
2019-12-14 00:12 UTC2019-12N021490-00166670502019-04-06U-1Drug product3f01610625f2…
2019-09-15 20:21 UTC2019-09N021490-00166670502019-04-06U-1Drug productb00525d2431f…
2019-07-19 19:46 UTC2019-07N021490-00166670502019-04-06U-1Drug productea99ee380514…