Application 202376

Type: ANDA
Sponsor: TORRENT

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	TABLET, DELAYED RELEASE;ORAL	20MG	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
A202376-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2013-11-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202376-001	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	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`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	A202376-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202376-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202376-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202376-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202376-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202376-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202376-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202376-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202376-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202376-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202376-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202376-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202376-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202376-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202376-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202376-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202376-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202376-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202376-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202376-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A202376-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A202376-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A202376-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A202376-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A202376-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A202376-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A202376-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A202376-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A202376-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A202376-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A202376-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A202376-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A202376-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A202376-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A202376-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A202376-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A202376-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A202376-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A202376-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A202376-001	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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole sodium	RABEPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	04e88b86-e1dd-4c56-8359-45fbcc161f7d	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376 ndc (product): 13668-107
Rabeprazole sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	1855ccab-c377-4962-9225-3c5adc62e2bd	2025-12-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376
Rabeprazole sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	d1444508-fe40-4f68-8350-52f13399e38a	2021-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202376 application number: ANDA202376 ndc (product): 63187-555

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 30 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
0904-6375	Rabeprazole sodium	Rabeprazole sodium	Major Pharmaceuticals	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
13668-107	Rabeprazole sodium	Rabeprazole sodium	Torrent Pharmaceuticals Limited	ANDA	Current
50090-3182	Rabeprazole sodium	Rabeprazole sodium	A-S Medication Solutions	ANDA	Current
50090-3182	Rabeprazole sodium	Rabeprazole sodium	A-S Medication Solutions	ANDA	Current
50436-1070	Rabeprazole sodium	Rabeprazole sodium	Unit Dose Services	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	DIRECT RX	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	Direct_Rx	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	Direct_Rx	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	Direct_Rx	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	Direct_Rx	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	DIRECT RX	ANDA	Current
61919-225	RABERPRAZOLE SODIUM D/R	RABERPRAZOLE SODIUM D/R	Direct_Rx	ANDA	Current
63187-555	Rabeprazole sodium	Rabeprazole sodium	Proficient Rx LP	ANDA	Current
63187-555	Rabeprazole sodium	Rabeprazole sodium	Proficient Rx LP	ANDA	Current
63187-555	Rabeprazole sodium	Rabeprazole sodium	Proficient Rx LP	ANDA	Current
68071-2173	Rabeprazole sodium	Rabeprazole sodium	NuCare Pharmaceuticals, Inc.	ANDA	Current
68788-9275	Rabeprazole sodium	Rabeprazole sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-9275	Rabeprazole sodium	Rabeprazole sodium	Preferred Pharmaceuticals Inc.	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current
71335-0518	Rabeprazole sodium	Rabeprazole sodium	Bryant Ranch Prepack	ANDA	Current