Home NDC 65162-558 TAYSOFY
Product NDC 65162-558
11-digit product format 651620558
Labeler code 65162
Product ID 65162-558_838f7530-bb7a-41e5-a68a-3d78b152d1fa
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate and Ethinyl Estradiol, and Ferrous Fumarate
Dosage form KIT
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA214292
Marketing category ANDA
Marketing start 2021-07-28
Marketing end 0000-00-00
Active strength 0
NDC exclude flag No
Listing certified through 2024-12-31
Current FDA listing Historical FDA.report record 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 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20
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.
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 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 782e0a99824c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL AB 2021-07-20 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A214292-001 NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE 0.02MG;1MG CAPSULE / ORAL 2021-07-20 a50c72e98297…
Observed Orange Book normalized TE history# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-558 TAYSOFY (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, AND FERROUS FUMARATE) KIT [AMNEAL PHARMACEUTICALS LLC] 17 Legacy NDC 20241031_5b7b33cf-7b58-4ba2-b819-9cd4602edc8b.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 65162-558-15 65162055815 5 CARTON in 1 TRAY (65162-558-15) > 1 BLISTER PACK in 1 CARTON (65162-558-58) > 1 KIT in 1 BLISTER PACK 5 carton 2021-07-28 0000-00-00 No No Current