Rabeprazole sodium

Product NDC: 50090-3182
Requested package NDC: 50090-3182-1
11-digit product format: 500903182
Labeler code: 50090
Product ID: 50090-3182_49beeddd-9818-4713-b1cd-1de19823f380
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: A-S Medication Solutions
Application: ANDA202376
Marketing category: ANDA
Marketing start: 2013-11-08
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	50090-3182	50090-3182-1	I	Inactivated by FDA		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 · 15 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`

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
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 · 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	A202376-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
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…`

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	A202376-001	AB	1	`caaa826d4ba7…`
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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
50090-3182-0	2023-01-30	C162847	48780-1	f386c64a-43cd-0266-e053-dadaa90a7c1a	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
50090-3182-1	2023-01-30	C162847	48780-1	f386c64a-43cd-0266-e053-dadaa90a7c1a	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
50090-3182-2	2023-01-30	C162847	48780-1	f386c64a-43cd-0266-e053-dadaa90a7c1a	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50090-3182-0	Rabeprazole sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	7
50090-3182-1	Rabeprazole sodium	90 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	90	7
50090-3182-2	Rabeprazole sodium	60 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	60	7

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50090-3182-0	EA - Each	50090-3182	6bc2b182-5d0d-4a12-bc06-20ac539045d1	1	2018-12-13
50090-3182-1	EA - Each	50090-3182	a2dd8de0-2bf0-4cc5-b500-21c20e481ba6	1	2019-05-02
50090-3182-2	EA - Each	50090-3182	0aae8a2f-85e6-493f-be3b-38ea056fe0b2	1	2019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50090-3182	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [A-S MEDICATION SOLUTIONS]	7	Legacy NDC, 3 package rows	20190427_ea013e44-8b21-46c5-bedf-7e956a3b8aa5.zip

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
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

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854868	RABEprazole sodium 20 MG Delayed Release Oral Tablet	PSN	ea013e44-8b21-46c5-bedf-7e956a3b8aa5	7
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	ea013e44-8b21-46c5-bedf-7e956a3b8aa5	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
50090-3182-1	50090318201	90 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (50090-3182-1)	2014-11-28	0000-00-00	No	No	Current