Home NDC 70700-326 Gallifrey
Product NDC 70700-326
11-digit product format 707000326
Labeler code 70700
Product ID 70700-326_87e7c941-eb02-5980-fc0e-08aee9b00f75
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Norethindrone Acetate
Dosage form TABLET
Route ORAL
Labeler Xiromed LLC
Application ANDA205278
Marketing category ANDA
Marketing start 2024-09-06
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 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 A205278-001 NORETHINDRONE ACETATE NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A205278-001 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 · 43 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 2026-09-14 22:38:34 2026-08 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 84e616aacf4f…2026-08-18 06:07:40 2026-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A205278-001 NORETHINDRONE ACETATE 5MG TABLET / ORAL AB 2016-11-10 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
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 Gallifrey
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 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000405 Internal RxNorm lookup 2696255 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 70700-326-50 Gallifrey 50 in 1 BOTTLE TABLET 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70700-326 GALLIFREY (NORETHINDRONE ACETATE) TABLET [XIROMED LLC] 1 Current NDC, 1 package rows 20241101_26130af6-221b-2349-81b6-0c0132d6e524.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70700-326-50 70700032650 50 TABLET in 1 BOTTLE (70700-326-50) 50 tablet 2024-09-06 No No Current