Home NDC 64850-300 Naltrexone Hydrochloride
Product NDC 64850-300
11-digit product format 648500300
Labeler code 64850
Product ID 64850-300_ce3d9c35-a4f0-43ab-862d-2b5def348737
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Elite Laboratories, Inc.
Application ANDA075274
Marketing category ANDA
Marketing start 2025-08-15
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 44 .
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 · 44 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 2026-10-15 13:18:30 2026-09 A075274-001 NALTREXONE HYDROCHLORIDE 50MG TABLET / ORAL AB 1999-05-26 c2088c7a36db…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 44 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
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 64850-300-01 Naltrexone Hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 3 64850-300-30 Naltrexone Hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3
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 Sample Exclude flag Status 64850-300-01 64850030001 100 TABLET, FILM COATED in 1 BOTTLE (64850-300-01) 2025-08-15 No No Current 64850-300-30 64850030030 30 TABLET, FILM COATED in 1 BOTTLE (64850-300-30) 2025-08-15 No No Current