Rabeprazole Sodium

Product NDC: 71335-0244
11-digit product format: 713350244
Labeler code: 71335
Product ID: 71335-0244_99bc4d0e-37f0-4be4-a7c9-4f9cc083ae7b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA090678
Marketing category: ANDA
Marketing start: 2013-11-08
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: 2026-12-31
Current FDA listing: Yes

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
A090678-001	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
A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090678-001	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	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090678-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2013-11-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090678-001	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	A090678-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090678-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090678-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090678-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090678-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090678-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090678-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090678-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090678-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090678-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090678-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090678-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090678-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090678-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090678-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090678-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090678-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090678-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090678-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090678-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090678-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090678-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090678-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090678-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090678-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090678-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090678-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090678-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090678-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090678-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090678-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090678-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090678-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090678-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090678-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090678-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090678-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090678-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090678-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090678-001	AB	1	`e64feba35796…`

Additional Listing Data#

Finished product: Yes
Brand name base: Rabeprazole Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
RABEPRAZOLE SODIUM	20 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
3L36P16U4R	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854868	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e6350638-99b0-474d-be75-ae2a3e1af2cf	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-0244-2	Rabeprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	11
71335-0244-3	Rabeprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	11
71335-0244-4	Rabeprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	11
71335-0244-5	Rabeprazole Sodium	28 in 1 BOTTLE	TABLET, DELAYED RELEASE	28	11
71335-0244-6	Rabeprazole Sodium	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-0244-2	EA - Each	71335-0244	68172964-0e7b-42e0-9032-af9ccc7b4b30	1	2018-01-12
71335-0244-3	EA - Each	71335-0244	b3c0ebe9-725f-465f-b77b-5c890e44c3e2	1	2018-01-12
71335-0244-4	EA - Each	71335-0244	b62dd525-a861-4996-96ac-c3cec6750f1e	1	2018-01-12
71335-0244-5	EA - Each	71335-0244	a2223416-56c3-474b-b3c0-05e24f773c62	1	2018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-0244	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	11	Current NDC, Legacy NDC, 5 package rows	20231205_e6350638-99b0-474d-be75-ae2a3e1af2cf.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Chartwell RX, LLC	c5c43222-d167-4152-b5c7-84b55920a7ce	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	14412af6-e99c-4264-bc34-28a6f139f252	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Golden State Medical Supply, Inc.	87231460-8b1e-b995-e053-2a91aa0a6c43	2024-04-16	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	e6350638-99b0-474d-be75-ae2a3e1af2cf	2023-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678 ndc (product): 71335-0244
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Lannett Company, Inc.	7f7d68f0-972b-4315-b712-0bb8a84c85cc	2023-07-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090678 application number: ANDA090678

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	e6350638-99b0-474d-be75-ae2a3e1af2cf	11
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	e6350638-99b0-474d-be75-ae2a3e1af2cf	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-0244-2	71335024402	90 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-2)	2021-04-01	0000-00-00	No	No	Current
71335-0244-3	71335024403	30 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-3)	2018-06-21	0000-00-00	No	No	Current
71335-0244-4	71335024404	60 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-4)	2018-06-19	0000-00-00	No	No	Current
71335-0244-5	71335024405	28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-5)	2022-05-02	0000-00-00	No	No	Current
71335-0244-6	71335024406	120 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-0244-6)	2022-05-02	0000-00-00	No	No	Current