Naltrexone Hydrochloride

Product NDC: 53401-008
11-digit product format: 534010008
Labeler code: 53401
Product ID: 53401-008_4f721786-dab7-3405-e063-6294a90a6bbb
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naltrexone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
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	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.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A075274-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A075274-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A075274-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A075274-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A075274-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A075274-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A075274-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A075274-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A075274-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A075274-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A075274-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A075274-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A075274-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A075274-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A075274-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A075274-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A075274-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A075274-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A075274-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A075274-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A075274-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A075274-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A075274-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A075274-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A075274-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A075274-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A075274-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A075274-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A075274-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A075274-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A075274-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A075274-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A075274-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A075274-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A075274-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A075274-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A075274-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A075274-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A075274-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A075274-001	AB	1	`f41ea6bd6efb…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4f720879-1772-e734-e063-6394a90a0cf4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
31849934-38d8-47fe-b84a-4d392838c14b	Product name	1	20170823
8e48b6b8-3a2f-4e0d-b7c9-38d70393b778	Product name	1	20161103
e4d463bc-c674-43cb-be06-82786f310d01	Product name	1	20150326
7a537f54-d322-5e54-a3a2-035d3e21c3c6	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53401-008-31	Naltrexone Hydrochloride	600 in 1 BOTTLE	TABLET, FILM COATED	600		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53401-008-31	EA - Each	53401-008	b172de94-e565-4d56-a3b8-04f11a711200	1	2026-05-22

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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	5fec6721-3611-44ec-b4b9-118472250b01	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	fdcfe000-09e0-44e4-8ebf-c52efb12ef60	2024-08-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	49b7b694-6fec-479b-be35-d03d816e13dd	2023-12-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z6375YW9SF	NALTREXONE HYDROCHLORIDE	16676-29-2	NALTREXONE HYDROCHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1483744	naltrexone HCl 50 MG Oral Tablet	PSN	4f720879-1772-e734-e063-6394a90a0cf4	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	4f720879-1772-e734-e063-6394a90a0cf4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
53401-008-31	53401000831	600 TABLET, FILM COATED in 1 BOTTLE (53401-008-31)	2026-04-14	2028-06-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP	Aphena Pharma Solutions - Tennessee, LLC	2026-04-14	HUMAN PRESCRIPTION DRUG LABEL	1