NALTREXONE HYDROCHLORIDE

Product NDC: 82804-199
11-digit product format: 828040199
Labeler code: 82804
Product ID: 82804-199_f3305f0b-fb9e-4009-b28f-47fe9b1b618b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALTREXONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: Proficient Rx LP
Application: ANDA090356
Marketing category: ANDA
Marketing start: 2012-02-29
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 1.

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
A090356-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		2012-02-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A090356-001	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 · 41 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
2026-02-19 14:30 UTC	2026-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090356-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	2012-02-24	`cb3db0bc1861…`

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	A090356-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090356-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090356-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090356-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090356-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090356-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090356-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090356-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090356-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090356-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090356-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090356-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090356-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090356-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090356-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090356-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090356-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090356-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090356-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090356-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090356-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090356-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090356-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090356-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090356-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090356-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090356-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090356-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090356-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090356-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090356-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090356-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090356-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090356-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090356-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090356-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090356-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090356-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090356-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090356-001	AB	1	`cb3db0bc1861…`

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
f3305f0b-fb9e-4009-b28f-47fe9b1b618b	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
82804-199-30	NALTREXONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82804-199-30	EA - Each	82804-199	da463dab-887a-46ab-a99a-b63419118755	1	2025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82804-199	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP]	1	Current NDC, 1 package rows	20250309_f3305f0b-fb9e-4009-b28f-47fe9b1b618b.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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	f821dd49-3fa7-4d33-99de-19023ff1ae65	2026-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	f9807ec0-3504-4c66-8efe-ea25f84c782b	2026-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Major Pharmaceuticals	69cb8573-08c1-4957-a768-6cd383f6a3f4	2026-06-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Coupler LLC	544f79a7-ca89-795d-e063-6294a90a8a97	2026-06-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	0f30f885-d0cd-4fa6-a8e0-142f08a56792	2026-06-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fa2f842f-001a-4f1e-8748-c7852579109c	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Proficient Rx LP	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	2025-02-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090356 application number: ANDA090356 ndc (product): 82804-199

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	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	1
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
82804-199-30	82804019930	30 TABLET, FILM COATED in 1 BOTTLE (82804-199-30)	2025-02-21	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	Proficient Rx LP	2025-02-01	HUMAN PRESCRIPTION DRUG LABEL	1