Home NDC 16729-081 Naltrexone Hydrochloride
Product NDC 16729-081
11-digit product format 167290081
Labeler code 16729
Product ID 16729-081_424db74c-6c0f-1eb3-e063-6294a90a7db8
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Accord Healthcare, Inc.
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 42 .
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 · 42 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 2026-08-18 06:07:40 2026-07 A091205-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 2011-08-17 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 42 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 16729-081-01 Naltrexone Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 5 16729-081-10 Naltrexone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 5 16729-081-16 Naltrexone Hydrochloride 500 in 1 BOTTLE TABLET, FILM COATED 500 5 16729-081-17 Naltrexone Hydrochloride 1000 in 1 BOTTLE TABLET, FILM COATED 1000 5
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded NALTREXONE HYDROCHLORIDE ACTIVE INGREDIENT Z6375YW9SF NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 NALTREXONE ACTIVE MOIETY 5S6W795CQM NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 16729-081 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [ACCORD HEALTHCARE, INC.] 4 Current NDC, Legacy NDC, 4 package rows 20240216_49aa3d6d-2270-4615-aafa-b440859ab870.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 16729-081-01 16729008101 100 TABLET, FILM COATED in 1 BOTTLE (16729-081-01) 2012-01-18 0000-00-00 No No Current 16729-081-10 16729008110 30 TABLET, FILM COATED in 1 BOTTLE (16729-081-10) 2012-01-18 0000-00-00 No No Current 16729-081-16 16729008116 500 in 1 BOTTLE Historical 16729-081-17 16729008117 1000 in 1 BOTTLE Historical