NALTREXONE HYDROCHLORIDE

Product NDC: 71610-964
11-digit product format: 716100964
Labeler code: 71610
Product ID: 71610-964_43cd684b-f17f-80ab-e063-6294a90a6f5a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: naltrexone hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA076264
Marketing category: ANDA
Marketing start: 2002-03-22
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 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A076264-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22
A076264-002	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22
A076264-003	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A076264-002	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 4 · 123 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
2026-02-19 14:30 UTC	2026-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076264-002	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	RS	2002-03-22	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076264-003	NALTREXONE HYDROCHLORIDE	100MG	TABLET / ORAL			2002-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076264-001	NALTREXONE HYDROCHLORIDE	25MG	TABLET / ORAL			2002-03-22	`8072bd15b7f6…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A076264-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A076264-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A076264-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A076264-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A076264-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A076264-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A076264-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A076264-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A076264-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A076264-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A076264-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A076264-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A076264-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A076264-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A076264-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A076264-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A076264-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A076264-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A076264-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A076264-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A076264-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A076264-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A076264-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A076264-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A076264-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A076264-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A076264-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A076264-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A076264-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A076264-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A076264-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A076264-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A076264-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A076264-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A076264-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A076264-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A076264-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A076264-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A076264-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A076264-002	AB	1	`cb3db0bc1861…`

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 · 8 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	43cd6961-4793-85ee-e063-6294a90ad772	2025-11-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264 ndc (product): 71610-964
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	0103a32b-14a9-48a8-8952-b2b12ef09649	2025-11-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390bff41-7bab-b72a-e063-6294a90ad35d	2025-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	American Health Packaging	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	2024-08-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	838a1e88-1179-4a2a-a737-8ce008bb96a7	2024-05-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	SpecGx LLC	06ff2d5a-e62b-4fa4-bbdb-01938535bc65	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	10261f2f-e4c1-415c-b722-edeaab97a112	2023-12-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 076264 application number: ANDA076264

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
43cd6961-4793-85ee-e063-6294a90ad772	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
71610-964-31	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
71610-964-31	EA - Each	71610-964	4183a958-71d2-42e4-b881-1c07ddd6fe06	1	2025-12-16

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	43cd6961-4793-85ee-e063-6294a90ad772	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	43cd6961-4793-85ee-e063-6294a90ad772	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
71610-964-31	71610096431	600 TABLET, FILM COATED in 1 BOTTLE (71610-964-31)	2025-11-13	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets USP 50 mg Opioid Antagonist Rx only	Aphena Pharma Solutions - Tennessee, LLC	2025-11-17	HUMAN PRESCRIPTION DRUG LABEL	1