Application 074918

Type: ANDA
Sponsor: BARR

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	TABLET;ORAL	50MG	No	No

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
A074918-001	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB		1998-05-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A074918-001	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	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074918-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1998-05-08	`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	A074918-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A074918-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A074918-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A074918-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A074918-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A074918-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A074918-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A074918-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A074918-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A074918-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A074918-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A074918-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A074918-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A074918-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A074918-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A074918-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A074918-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A074918-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A074918-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A074918-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A074918-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A074918-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A074918-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A074918-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A074918-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A074918-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A074918-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A074918-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A074918-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A074918-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A074918-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A074918-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A074918-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A074918-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A074918-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A074918-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A074918-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A074918-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A074918-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A074918-001	AB	1	`f41ea6bd6efb…`

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 3 · 44 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	8f019ac1-13a8-42f2-bdb2-8aaef5896d96	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b5d0b9d2-8d98-4800-855e-7e8054eadf68	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	TAGI Pharma Inc.	60276f5c-657a-4b60-bcd0-44234903d7e0	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	b09b4b5e-795a-48e7-b7cc-2e29f41c5660	2025-11-18	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	43cd6961-4793-85ee-e063-6294a90ad772	2025-11-17	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	0103a32b-14a9-48a8-8952-b2b12ef09649	2025-11-12	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Heritage Pharmaceuticals Inc d/b/a Avet Pharmaceuticals Inc	c67a22bb-d2bd-4da5-9d3e-6b5281f10891	2025-10-30	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Accord Healthcare, Inc.	49aa3d6d-2270-4615-aafa-b440859ab870	2025-10-29	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	637ed3da-476d-4f95-8bbc-f93eaa0aa57e	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	NCS HealthCare of KY, LLC dba Vangard Labs	fa2f842f-001a-4f1e-8748-c7852579109c	2025-09-03	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Golden State Medical Supply, Inc.	3cbd0cad-7c56-ac0a-e063-6294a90a80e4	2025-08-19	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	68cb0399-ca56-4310-8531-6b5552b71b25	2025-07-29	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d7ba0156-6222-4619-a043-b5a1342d5375	2025-07-28	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	74087d2f-468d-4de1-a2fc-a489d0f2abef	2025-07-09	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	390bff41-7bab-b72a-e063-6294a90ad35d	2025-07-03	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Proficient Rx LP	f3305f0b-fb9e-4009-b28f-47fe9b1b618b	2025-02-01	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	NuCare Pharmaceuticals Inc.	1e059495-5e64-0cb0-e063-6394a90a3ffc	2024-12-26	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	5fec6721-3611-44ec-b4b9-118472250b01	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	fdcfe000-09e0-44e4-8ebf-c52efb12ef60	2024-08-27	Warnings, Adverse reactions	Name fallback brand name: Naltrexone Hydrochloride generic name: NALTREXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	American Health Packaging	81e25c6a-81b6-4cfb-91bf-be20c3ae546b	2024-08-05	Warnings, Adverse reactions	Name fallback brand name: NALTREXONE HYDROCHLORIDE generic name: NALTREXONE HYDROCHLORIDE

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Documents#

Document, Submission type, Date table
Document	Submission type	Date
42897	ORIG	1998-05-08
30716	ORIG	1998-05-08