Home NDC 68094-853 Naltrexone Hydrochloride
Product NDC 68094-853
11-digit product format 680940853
Labeler code 68094
Product ID 68094-853_7670a1a9-f14e-4e9e-8b3e-f8d5e52125e0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name naltrexone Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Precision Dose Inc.
Application ANDA075274
Marketing category ANDA
Marketing start 2014-10-29
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 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
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 68094-853-59 Naltrexone Hydrochloride 10 in 1 BLISTER PACK TABLET, FILM COATED 10 6 68094-853-61 Naltrexone Hydrochloride 10 in 1 CARTON TABLET, FILM COATED 10 6 68094-853-62 Naltrexone Hydrochloride 3 in 1 CARTON TABLET, FILM COATED 3 6 68094-853-66 Naltrexone Hydrochloride 2 in 1 CARTON TABLET, FILM COATED 2 6
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 [PRECISION DOSE INC.] 1 naltrexone ACTIVE MOIETY 5S6W795CQM NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 anhydrous lactose INACTIVE INGREDIENT 3SY5LH9PMK NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 cellulose, microcrystalline INACTIVE INGREDIENT OP1R32D61U NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 croscarmellose sodium INACTIVE INGREDIENT M28OL1HH48 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 ferric oxide yellow INACTIVE INGREDIENT EX438O2MRT NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 hydroxypropyl cellulose (type h) INACTIVE INGREDIENT RFW2ET671P NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 magnesium stearate INACTIVE INGREDIENT 70097M6I30 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 silicon dioxide INACTIVE INGREDIENT ETJ7Z6XBU4 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68094-853 NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PRECISION DOSE INC.] 5 Current NDC, Legacy NDC, 4 package rows 20241017_74087d2f-468d-4de1-a2fc-a489d0f2abef.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 Units Marketing start Marketing end Sample Exclude flag Status 68094-853-59 68094085359 10 in 1 BLISTER PACK Historical 68094-853-61 68094085361 10 BLISTER PACK in 1 CARTON (68094-853-61) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) 10 blister pack 2024-08-15 No No Current 68094-853-62 68094085362 3 BLISTER PACK in 1 CARTON (68094-853-62) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) 3 blister pack 2014-10-29 2026-12-31 No No Current 68094-853-66 68094085366 2 BLISTER PACK in 1 CARTON (68094-853-66) / 10 TABLET, FILM COATED in 1 BLISTER PACK (68094-853-59) 2 blister pack 2024-08-15 No No Current