Home NDC 42291-632 Naltrexone Hydrochloride
Product NDC 42291-632
11-digit product format 422910632
Labeler code 42291
Product ID 42291-632_4a197f32-b382-2a52-e063-6394a90ad197
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler AvKARE
Application ANDA075274
Marketing category ANDA
Marketing start 2015-03-26
Marketing end 2028-06-30
Substance NALTREXONE HYDROCHLORIDE
Active strength 50 mg/1
Pharmacologic classes Opioid Antagonist [EPC], Opioid Antagonists [MoA]
NDC exclude flag No
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 A075274-001 NALTREXONE HYDROCHLORIDE NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A075274-001 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 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 84e616aacf4f…2026-08-18 06:07:40 2026-07 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 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 Naltrexone Hydrochloride 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 42291-632-30 Naltrexone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 10 42291-632-60 Naltrexone Hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 10
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Naltrexone Hydrochloride ACTIVE INGREDIENT Z6375YW9SF NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 Naltrexone ACTIVE MOIETY 5S6W795CQM NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 hydroxypropyl cellulose (type h) INACTIVE INGREDIENT RFW2ET671P NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NALTREXONE HYDROCHLORIDE (NALTREXONE HYDROCHLORIDE) TABLET, FILM COATED [AVKARE, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 42291-632 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [AVKARE] 7 Current NDC, Legacy NDC, 2 package rows 20240802_21b43dab-015c-c82f-ba6e-27da0ec12fc5.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 2 of 2 · 23 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 42291-632-30 42291063230 30 TABLET, FILM COATED in 1 BOTTLE (42291-632-30) 2015-03-26 2028-06-30 No No Current 42291-632-60 42291063260 60 TABLET, FILM COATED in 1 BOTTLE (42291-632-60) 2025-07-24 2028-06-30 No No Historical