Rabeprazole Sodium

Product NDC: 70934-403
11-digit product format: 709340403
Labeler code: 70934
Product ID: 70934-403_adb91b0c-25bd-5626-e053-2a95a90ac5bd
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application: ANDA208644
Marketing category: ANDA
Marketing start: 2019-07-08
Marketing end: 0000-00-00
Substance: RABEPRAZOLE SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	70934-403		D	Discontinued by firm		2026-08-17
excluded package	package	70934-403	70934-403-60	D	Discontinued by firm		2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	70934-403-60	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	70934-403-60	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	70934-403-60	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	70934-403-60	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	70934-403-60	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	70934-403-60	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	70934-403-60	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	70934-403-60	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	70934-403-60	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	70934-403-60	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	70934-403-60	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	70934-403-60	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	70934-403-60	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	70934-403-60	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	70934-403-60	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`

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
A208644-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2018-04-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A208644-001	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	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208644-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2018-04-24	`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	A208644-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208644-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208644-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208644-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208644-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208644-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208644-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208644-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208644-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208644-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208644-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208644-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208644-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208644-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208644-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208644-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208644-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208644-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208644-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208644-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208644-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208644-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208644-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208644-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208644-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208644-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208644-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208644-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208644-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208644-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208644-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208644-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208644-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208644-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208644-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208644-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208644-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208644-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208644-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A208644-001	AB	1	`e64feba35796…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
70934-403-60	2023-02-07	C162847	48780-1	d6a99b39-63df-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999
70934-403-60	2022-01-28	C162847	48780-1	d6a99b39-63df-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE TABLETS. RABEPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. Approval: 1999

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 · 13 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole Sodium	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	63e0b7ca-6b2d-42a9-b9d4-4523b8a20425	2026-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	9237eaa4-8eec-fb2a-e053-2995a90ab6c0	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	68b7a793-f22b-4609-a640-94fdec703d93	2026-05-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bdad0b58-495e-2352-e053-2a95a90a3198	2026-03-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b354053c-cb83-79c6-e053-2a95a90afdbe	2026-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	3b6a25c2-fb61-4c86-9988-c6ffac7939c4	2026-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ac9266ed-a9b2-4e77-8607-393b5dcdd2b6	2025-09-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	PHOENIX RX LLC	3a674849-b2f6-5f43-e063-6294a90a9e20	2025-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	9ea2552c-873c-4ab2-84b0-dd54e84e4eee	2024-08-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	8d8c1a72-b4c4-4699-b9c3-3a39a9df44f2	2024-07-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Ascend Laboratories, LLC	45092108-7c4a-48f9-8222-ca8612e82189	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644
Rabeprazole Sodium	RABEPRAZOLE SODIUM	A-S Medication Solutions	4ded337a-31b8-47c3-b5ab-33a785afb7d8	2023-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208644 application number: ANDA208644

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3L36P16U4R	RABEPRAZOLE SODIUM	117976-90-6	RABEPRAZOLE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
70934-403-60	70934040360	60 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (70934-403-60)	2019-07-08	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rabeprazole Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2020-08-25	HUMAN PRESCRIPTION DRUG LABEL	2