Home NDC 50090-4925 Naltrexone Hydrochloride
Product NDC 50090-4925
11-digit product format 500904925
Labeler code 50090
Product ID 50090-4925_4242e317-1764-436a-aff6-338a58f1b0a2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler A-S Medication Solutions
Application ANDA091205
Marketing category ANDA
Marketing start 2012-01-18
Substance NALTREXONE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
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 A091205-001 NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A091205-001 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 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 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 Naltrexone Hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength NALTREXONE HYDROCHLORIDE 50 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z6375YW9SF Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1483744 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 50090-4925-0 Naltrexone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50090-4925 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS] 5 Current NDC, Legacy NDC, 1 package rows 20231216_00c04ff4-b6f2-466c-9ab9-813a60577db0.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 · 4 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50090-4925-0 50090492500 30 TABLET, FILM COATED in 1 BOTTLE (50090-4925-0) 2020-02-20 0000-00-00 No No Current