Home NDC 65162-475 Norethindrone Acetate
Product NDC 65162-475
11-digit product format 651620475
Labeler code 65162
Product ID 65162-475_764f6075-288a-4435-b148-35589e5e5835
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone
Dosage form TABLET
Route ORAL
Labeler Amneal Pharmaceuticals LLC
Application ANDA200275
Marketing category ANDA
Marketing start 2009-07-01
Substance NORETHINDRONE ACETATE
Active strength 5 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
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 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 A200275-001 NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200275-001 AB
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 · 41 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 2026-02-19 14:30 UTC 2026-02 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200275-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2012-07-30 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Norethindrone Acetate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE ACETATE 5 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 9S44LIC7OJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000405 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 65162-475-03 Norethindrone Acetate 30 in 1 BOTTLE TABLET 30 18 65162-475-05 Norethindrone Acetate 50 in 1 BOTTLE TABLET 50 18 65162-475-09 Norethindrone Acetate 90 in 1 BOTTLE TABLET 90 18 65162-475-50 Norethindrone Acetate 500 in 1 BOTTLE TABLET 500 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 NORETHINDRONE ACTIVE MOIETY T18F433X4S NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 LACTOSE, UNSPECIFIED FORM INACTIVE INGREDIENT J2B2A4N98G NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC] 12 NORETHINDRONE ACETATE ACTIVE INGREDIENT 9S44LIC7OJ NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] 1 NORETHINDRONE ACTIVE MOIETY T18F433X4S NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] 1 LACTOSE INACTIVE INGREDIENT J2B2A4N98G NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65162-475 NORETHINDRONE ACETATE (NORETHINDRONE) TABLET [AMNEAL PHARMACEUTICALS LLC] 18 Current NDC, Legacy NDC, 4 package rows 20241031_64cb920c-36e8-4d62-9d08-3ddf3989d313.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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 65162-475-03 65162047503 30 TABLET in 1 BOTTLE (65162-475-03) 30 tablet 2009-07-01 0000-00-00 No No Current 65162-475-05 65162047505 50 TABLET in 1 BOTTLE (65162-475-05) 50 tablet 2009-07-01 0000-00-00 No No Current 65162-475-09 65162047509 90 TABLET in 1 BOTTLE (65162-475-09) 90 tablet 2009-07-01 0000-00-00 No No Current 65162-475-50 65162047550 500 TABLET in 1 BOTTLE (65162-475-50) 500 tablet 2009-07-01 0000-00-00 No No Current