Home NDC 71335-0014 Naltrexone Hydrochloride
Product NDC 71335-0014
11-digit product format 713350014
Labeler code 71335
Product ID 71335-0014_63e4eb6a-b262-44d1-974b-633876a9c563
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Bryant Ranch Prepack
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 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 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.
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.
Additional Listing Data#
Finished product Yes
Brand name base Naltrexone Hydrochloride
Listing expiration 2027-12-31 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 71335-0014-1 Naltrexone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 13 71335-0014-2 Naltrexone Hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 13 71335-0014-3 Naltrexone Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 13 71335-0014-4 Naltrexone Hydrochloride 45 in 1 BOTTLE TABLET, FILM COATED 45 13 71335-0014-5 Naltrexone Hydrochloride 120 in 1 BOTTLE TABLET, FILM COATED 120 13 71335-0014-6 Naltrexone Hydrochloride 15 in 1 BOTTLE TABLET, FILM COATED 15 13 71335-0014-7 Naltrexone Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 13
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 71335-0014 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [BRYANT RANCH PREPACK] 12 Current NDC, Legacy NDC, 7 package rows 20240510_fa0b0881-97f3-4ca2-bc15-0954293081db.zip
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 71335-0014-1 71335001401 30 TABLET, FILM COATED in 1 BOTTLE (71335-0014-1) 2026-05-14 0000-00-00 No No Current 71335-0014-2 71335001402 90 TABLET, FILM COATED in 1 BOTTLE (71335-0014-2) 2026-05-14 0000-00-00 No No Current 71335-0014-3 71335001403 60 TABLET, FILM COATED in 1 BOTTLE (71335-0014-3) 2026-05-14 0000-00-00 No No Current 71335-0014-4 71335001404 45 TABLET, FILM COATED in 1 BOTTLE (71335-0014-4) 2026-05-14 0000-00-00 No No Current 71335-0014-5 71335001405 120 TABLET, FILM COATED in 1 BOTTLE (71335-0014-5) 2026-05-14 0000-00-00 No No Current 71335-0014-6 71335001406 15 TABLET, FILM COATED in 1 BOTTLE (71335-0014-6) 2026-05-14 0000-00-00 No No Current 71335-0014-7 71335001407 100 TABLET, FILM COATED in 1 BOTTLE (71335-0014-7) 2026-05-14 No No Current