Application 090356

Type: ANDA
Sponsor: SUN PHARM

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
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…`

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 ndc (product): 70518-2718
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 ndc (product): 71335-2062
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 ndc (product): 0904-7036
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 ndc (product): 47335-326
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 Listings For This Application#

NDC listings for this application page 1 of 1 · 9 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-7036	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
0904-7036	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Major Pharmaceuticals	ANDA	Current
47335-326	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Sun Pharmaceutical Industries, Inc.	ANDA	Current
50090-3929	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
50090-3929	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	A-S Medication Solutions	ANDA	Current
70518-2718	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2718	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
70518-2718	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	REMEDYREPACK INC.	ANDA	Current
71335-2062	NALTREXONE HYDROCHLORIDE	NALTREXONE HYDROCHLORIDE	Bryant Ranch Prepack	ANDA	Current