Home NDC 72789-439 Norethindrone
Product NDC 72789-439
11-digit product format 727890439
Labeler code 72789
Product ID 72789-439_2e82440c-7f1b-f694-e063-6394a90a5646
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone
Dosage form TABLET
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA200980
Marketing category ANDA
Marketing start 2013-06-24
Marketing end 2026-05-31
Substance NORETHINDRONE
Active strength .35 mg/1
Pharmacologic classes Progesterone Congeners [CS], Progestin [EPC]
NDC exclude flag No
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 A200980-001 NORETHINDRONE NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A200980-001 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 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A200980-001 NORETHINDRONE 0.35MG TABLET / ORAL-28 AB2 RS 2013-06-12 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-439-79 Norethindrone 1 in 1 POUCH TABLET 1 13 72789-439-79 Norethindrone 28 in 1 BLISTER PACK TABLET 28 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-439 NORETHINDRONE TABLET [PD-RX PHARMACEUTICALS, INC.] 12 Current NDC, 2 package rows 20241017_19e77ccf-1138-4efa-a7f3-8367cc1e69a6.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 MELEYA NORETHINDRONE Xiromed LLC 534c5717-382c-4109-3208-e21b32e4c4c9 2025-03-06 Warnings, Adverse reactions Exact identifier application applno (ANDA): 200980 application number: ANDA200980
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 72789-439-79 72789043979 1 BLISTER PACK in 1 POUCH (72789-439-79) / 28 TABLET in 1 BLISTER PACK 1 blister pack 2024-10-15 2026-05-31 No No Historical