Application 075274

Type: ANDA
Sponsor: ELITE LABS

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 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
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 · 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	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…`
2022-09-29 23:25 UTC	2022-09	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075274-001	NALTREXONE HYDROCHLORIDE	50MG	TABLET / ORAL	AB	1999-05-26	`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	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…`
2022-09-29 23:25 UTC	2022-09	A075274-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A075274-001	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 2 · 24 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	57e8b767-54c2-dfa3-e063-6394a90ae6c2	2026-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Coupler LLC	56055980-d23b-ec7d-e063-6394a90a9cc2	2026-05-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Elite Laboratories, Inc.	5f188bdc-2009-43aa-ad32-f06dbfac2642	2026-05-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	ab5b3829-96e5-4123-967a-29b41f13a4f7	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Aphena Pharma Solutions - Tennessee, LLC	4f720879-1772-e734-e063-6394a90a0cf4	2026-04-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d8433c5e-deb3-4f20-aaf6-9fed6bc44974	2026-03-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	7976b328-ad8e-4208-9f61-19cd5ab5f36b	2026-03-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b773726e-1dc9-415a-81f3-32b43b61b9b1	2026-03-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274 ndc (product): 63629-1047
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	AvKARE	21b43dab-015c-c82f-ba6e-27da0ec12fc5	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274 ndc (product): 42291-632
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	a328c3e1-9132-491d-ae5b-45fd27ca4993	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d4d0537b-113a-4e49-bb50-bf5ddafe6b7d	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	8f019ac1-13a8-42f2-bdb2-8aaef5896d96	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	b5d0b9d2-8d98-4800-855e-7e8054eadf68	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	TAGI Pharma Inc.	60276f5c-657a-4b60-bcd0-44234903d7e0	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274 ndc (product): 51224-206
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	b09b4b5e-795a-48e7-b7cc-2e29f41c5660	2025-11-18	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	db911559-26f5-43a0-b61f-3425176c936f	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	637ed3da-476d-4f95-8bbc-f93eaa0aa57e	2025-09-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	68cb0399-ca56-4310-8531-6b5552b71b25	2025-07-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	d7ba0156-6222-4619-a043-b5a1342d5375	2025-07-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274
Naltrexone Hydrochloride	NALTREXONE HYDROCHLORIDE	Precision Dose Inc.	74087d2f-468d-4de1-a2fc-a489d0f2abef	2025-07-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 075274 application number: ANDA075274 ndc (product): 68094-853

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 21 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
42291-632	Naltrexone Hydrochloride	Naltrexone Hydrochloride	AvKARE, Inc.	ANDA	Current
42291-632	Naltrexone Hydrochloride	Naltrexone Hydrochloride	AvKARE	ANDA	Current
50090-2866	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-2866	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
50090-3076	Naltrexone Hydrochloride	Naltrexone Hydrochloride	A-S Medication Solutions	ANDA	Current
51224-206	Naltrexone Hydrochloride	Naltrexone Hydrochloride	TAGI Pharma Inc.	ANDA	Current
51224-206	Naltrexone Hydrochloride	Naltrexone Hydrochloride	TAGI Pharma Inc.	ANDA	Current
53217-261	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Aidarex Pharmaceuticals LLC	ANDA	Current
63629-1046	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1046	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1046	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1046	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1047	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1047	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
63629-1047	Naltrexone Hydrochloride	Naltrexone Hydrochloride	Bryant Ranch Prepack	ANDA	Current
68071-2156	Naltrexone Hydrochloride	Naltrexone Hydrochloride	NuCare Pharmaceuticls, Inc.	ANDA	Current
68071-2156	Naltrexone Hydrochloride	Naltrexone Hydrochloride	NuCare Pharmaceuticls, Inc.	ANDA	Current
68094-853	Naltrexone Hydrochloride	naltrexone Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-853	Naltrexone Hydrochloride	naltrexone Hydrochloride	Precision Dose Inc.	ANDA	Current
68094-853	Naltrexone Hydrochloride	naltrexone Hydrochloride	Precision Dose Inc.	ANDA	Current
76519-1160	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	H.J. Harkins Company Inc.	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
22452	ORIG	1999-05-26
8593	ORIG	1999-05-26