Rabeprazole Sodium

Product NDC: 76420-107
Requested package NDC: 76420-107-90
11-digit product format: 764200107
Labeler code: 76420
Product ID: 76420-107_a8f5a654-c183-044b-e053-2995a90af261
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Rabeprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA205761
Marketing category: ANDA
Marketing start: 2017-02-17
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 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
A205761-001	RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB		2017-02-17

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205761-001	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	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205761-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2017-02-17	`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	A205761-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205761-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205761-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205761-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205761-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205761-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205761-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205761-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205761-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205761-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205761-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205761-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205761-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205761-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205761-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205761-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205761-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205761-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205761-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A205761-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A205761-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A205761-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A205761-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A205761-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A205761-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A205761-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A205761-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A205761-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A205761-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A205761-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A205761-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A205761-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A205761-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A205761-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A205761-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A205761-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A205761-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A205761-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A205761-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A205761-001	AB	1	`cb3db0bc1861…`

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
12eaf996-db61-41d6-82e1-fa6196435603	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-107-30	Rabeprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
76420-107-60	Rabeprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1
76420-107-90	Rabeprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
76420-107-60	EA - Each	76420-107	35dbd013-5b7f-4dcd-90a9-6a4c91493ab4	1	2021-01-08
76420-107-90	EA - Each	76420-107	836a457b-ef80-422a-a443-2fde2c5b5555	1	2021-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-107	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 3 package rows	20200627_12eaf996-db61-41d6-82e1-fa6196435603.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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf	2024-05-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Aurobindo Pharma Limited	d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89	2024-02-28	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	12eaf996-db61-41d6-82e1-fa6196435603	2020-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205761 application number: ANDA205761 ndc (package): 76420-107-90 ndc (product): 76420-107 ndc11 (package): 76420010790

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	12eaf996-db61-41d6-82e1-fa6196435603	1
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	12eaf996-db61-41d6-82e1-fa6196435603	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-107-90	76420010790	90 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-107-90)	2020-06-26	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rabeprazole Sodium	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2020-06-26	HUMAN PRESCRIPTION DRUG LABEL	1