Home NDC 68462-305 Norethindrone
Product NDC 68462-305
11-digit product format 684620305
Labeler code 68462
Product ID 68462-305_5a1f7007-bfeb-4899-a1a3-b3c005cbcabb
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone
Dosage form TABLET
Route ORAL
Labeler Glenmark Pharmaceuticals Inc., USA
Application ANDA091209
Marketing category ANDA
Marketing start 2010-11-03
Substance NORETHINDRONE
Active strength .35 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A091209-001 NORETHINDRONE NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091209-001 AB2
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 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091209-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 2010-07-22 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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NORETHINDRONE .35 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T18F433X4S Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198042 Internal RxNorm lookup 748961 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 68462-305-29 Norethindrone 3 in 1 CARTON TABLET 3 8 68462-305-84 Norethindrone 28 in 1 POUCH TABLET 28 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NORETHINDRONE ACTIVE INGREDIENT T18F433X4S NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 NORETHINDRONE ACTIVE MOIETY T18F433X4S NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 ANHYDROUS LACTOSE INACTIVE INGREDIENT 3SY5LH9PMK NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 D&C YELLOW NO. 10 INACTIVE INGREDIENT 35SW5USQ3G NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 ETHYLCELLULOSES INACTIVE INGREDIENT 7Z8S9VYZ4B NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 POVIDONES INACTIVE INGREDIENT FZ989GH94E NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 STARCH, CORN INACTIVE INGREDIENT O8232NY3SJ NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4 TALC INACTIVE INGREDIENT 7SEV7J4R1U NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-305 NORETHINDRONE TABLET [GLENMARK PHARMACEUTICALS INC., USA] 7 Current NDC, Legacy NDC, 2 package rows 20240104_0d2f8fea-3675-40d2-afd9-9fcb148dbd4b.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 68462-305-29 68462030529 3 POUCH in 1 CARTON (68462-305-29) / 28 TABLET in 1 POUCH (68462-305-84) 3 pouch 2010-11-03 0000-00-00 No No Current 68462-305-84 68462030584 28 in 1 POUCH Historical