Home NDC 59651-504 OSHIH
Product NDC 59651-504
11-digit product format 596510504
Labeler code 59651
Product ID 59651-504_3bf10185-1849-49a1-9b3b-ba35a0413408
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name norethindrone acetate and ethinyl estradiol and ferrous fumarate
Dosage form KIT
Labeler Aurobindo Pharma Limited
Application ANDA216558
Marketing category ANDA
Marketing start 2023-12-06
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A216558-001 OSHIH ETHINYL ESTRADIOL; NORETHINDRONE ACETATE 0.02MG;1MG TABLET / ORAL 2023-12-06
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 2026-09-14 22:38:34 2026-08 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 84e616aacf4f…2026-08-18 06:07:40 2026-07 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL AB 2023-12-06 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL AB 2023-12-06 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL AB 2023-12-06 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL AB 2023-12-06 ea1830bbd6c7…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A216558-001 OSHIH 0.02MG;1MG TABLET / ORAL 2023-12-06 a50c72e98297…
Observed Orange Book normalized TE history# Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base OSHIH
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259176 Internal RxNorm lookup 1426288 Internal RxNorm lookup 1426600 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-504-88 OSHIH 3 in 1 CARTON KIT 3 2 59651-504-88 OSHIH 1 in 1 POUCH KIT 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59651-504 OSHIH (NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE) KIT [AUROBINDO PHARMA LIMITED] 2 Current NDC, 2 package rows 20240216_7c07e339-3aae-4c77-a170-e6715bbe7563.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join OSHIH NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE Aurobindo Pharma Limited 7c07e339-3aae-4c77-a170-e6715bbe7563 2024-02-03 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 216558 application number: ANDA216558 ndc (product): 59651-504
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-504-88 59651050488 3 POUCH in 1 CARTON (59651-504-88) / 1 BLISTER PACK in 1 POUCH / 1 KIT in 1 BLISTER PACK 3 pouch 2023-12-06 No No Current