Naltrexone Hydrochloride

Product NDC: 67046-0060
11-digit product format: 670460060
Labeler code: 67046
Product ID: 67046-0060_52ceb015-f798-e329-e063-6294a90a527e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Naltrexone Hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Coupler LLC
Application: ANDA075274
Marketing category: ANDA
Marketing start: 2026-05-27
Marketing end: 2027-11-30
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
56055980-d23b-ec7d-e063-6394a90a9cc2	Available on FDA.report

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
67046-0060-3	67046006003	30 TABLET, FILM COATED in 1 BLISTER PACK (67046-0060-3)	2026-05-27	2027-11-30	No	No	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP	Coupler LLC \| Elite Laboratories, Inc.	2026-05-27	HUMAN PRESCRIPTION DRUG LABEL	1