NALTREXONE HYDROCHLORIDE

Product NDC: 50090-3929
Requested package NDC: 50090-3929-0
11-digit product format: 500903929
Labeler code: 50090
Product ID: 50090-3929_7b8b9aa6-4484-4b2b-b17f-63042d1b467c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: NALTREXONE HYDROCHLORIDE
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA090356
Marketing category: ANDA
Marketing start: 2012-02-29
Marketing end: 0000-00-00
Substance: NALTREXONE HYDROCHLORIDE
Active strength: 50 mg/1
Pharmacologic classes: Opioid Antagonist [EPC],Opioid Antagonists [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3929	50090-3929-0	I	Inactivated by FDA		2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 15 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3929-0	2023-01-30	C162847	48780-1	f386c649-cc6d-0266-e053-dadaa90a7c1a	Naltrexone Hydrochloride Tablets, USP Opioid Antagonist

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50090-3929-0	NALTREXONE HYDROCHLORIDE	30 in 1 BOTTLE	TABLET, FILM COATED	30		4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3929	NALTREXONE HYDROCHLORIDE TABLET, FILM COATED [A-S MEDICATION SOLUTIONS]	4	Legacy NDC, 1 package rows	20200122_e71de213-5250-4a63-9ef7-9ef2f9954d8b.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

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	e71de213-5250-4a63-9ef7-9ef2f9954d8b	4
1483744	naltrexone hydrochloride 50 MG Oral Tablet	SCD	e71de213-5250-4a63-9ef7-9ef2f9954d8b	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3929-0	50090392900	30 TABLET, FILM COATED in 1 BOTTLE (50090-3929-0)	2018-12-07	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Naltrexone Hydrochloride Tablets, USP Opioid Antagonist	A-S Medication Solutions	2020-01-18	Human Prescription Drug Label	4