Application 204237

Type: ANDA
Sponsor: RUBICON

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 42.

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
A204237-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2015-11-18

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A204237-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A204237-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A204237-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A204237-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A204237-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A204237-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A204237-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A204237-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A204237-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A204237-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A204237-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A204237-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A204237-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A204237-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A204237-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A204237-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A204237-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A204237-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A204237-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A204237-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A204237-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A204237-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A204237-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A204237-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A204237-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A204237-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A204237-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A204237-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A204237-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A204237-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A204237-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A204237-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A204237-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A204237-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A204237-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A204237-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A204237-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A204237-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A204237-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A204237-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A204237-001	AB	1	`e64feba35796…`

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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	0e2e00fa-c4c5-4de7-adf9-cd9786b97016	2026-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237 ndc (product): 70518-3209
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	c212c9d5-32d3-3c5f-e053-2a95a90af88b	2026-06-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237 ndc (product): 60760-972
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9	2026-05-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	350c20b0-1879-d4cb-e063-6294a90a37f2	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advagen Pharma Limited	b1a12c83-74ab-febc-e053-2a95a90a1441	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237 ndc (product): 72888-059
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	4582d443-f1be-4f94-85da-49aa603f54e4	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	0863f340-4c7e-379a-e063-6394a90a758d	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	26f8c3bc-4402-e92c-e063-6294a90a9ad7	2024-11-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	A-S Medication Solutions	bafff1ac-02fb-4726-b2d7-6e099ae981cb	2023-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	9881dbb2-1ce2-4737-989f-b26720791ca5	2022-07-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237 ndc (product): 76420-223
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Proficient Rx LP	0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d	2022-04-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 204237 application number: ANDA204237 ndc (product): 71205-603

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 16 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
50090-3430	Rabeprazole Sodium	RABEPRAZOLE SODIUM	A-S Medication Solutions	ANDA	Current
51991-683	Rabeprazole Sodium	RABEPRAZOLE SODIUM	Breckenridge Pharmaceutical, Inc.	ANDA	Current
60760-972	RABEPRAZOLE SODIUM	rabeprazole sodium	St. Mary's Medical Park Pharmacy	ANDA	Current
63187-945	Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	ANDA	Current
68071-4353	Rabeprazole Sodium	RABEPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	ANDA	Current
68788-7143	Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	ANDA	Current
68788-7143	Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	ANDA	Current
70518-3209	RABEPRAZOLE SODIUM	rabeprazole sodium	REMEDYREPACK INC.	ANDA	Current
70518-3209	RABEPRAZOLE SODIUM	rabeprazole sodium	REMEDYREPACK INC.	ANDA	Current
70518-3209	RABEPRAZOLE SODIUM	rabeprazole sodium	REMEDYREPACK INC.	ANDA	Current
71205-603	RABEPRAZOLE SODIUM	rabeprazole sodium	Proficient Rx LP	ANDA	Current
71205-603	RABEPRAZOLE SODIUM	rabeprazole sodium	Proficient Rx LP	ANDA	Current
71335-0636	Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	ANDA	Current
72888-059	RABEPRAZOLE SODIUM	rabeprazole sodium	Advagen Pharma Limited	ANDA	Current
72888-059	RABEPRAZOLE SODIUM	rabeprazole sodium	Advagen Pharma Limited	ANDA	Current
76420-223	RABEPRAZOLE SODIUM	rabeprazole sodium	Asclemed USA, Inc.	ANDA	Current