RABEPRAZOLE SODIUM

Product NDC: 76420-223
Requested package NDC: 76420-223-60
11-digit product format: 764200223
Labeler code: 76420
Product ID: 76420-223_e347fcb2-dbe0-193d-e053-2995a90a4784
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Asclemed USA, Inc.
Application: ANDA204237
Marketing category: ANDA
Marketing start: 2017-06-01
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
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 · 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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204237-001	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	2015-11-18	`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	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…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A204237-001	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
9881dbb2-1ce2-4737-989f-b26720791ca5	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
76420-223-30	RABEPRAZOLE SODIUM	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
76420-223-60	RABEPRAZOLE SODIUM	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1
76420-223-90	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
76420-223-30	EA - Each	76420-223	7ce82a96-2647-4290-b6bd-bf53f0175b1f	1	2022-08-04
76420-223-60	EA - Each	76420-223	a0cab7e9-a729-427c-bd3b-ff9f0c90f409	1	2022-08-04
76420-223-90	EA - Each	76420-223	e647b1f5-3ee6-430a-b578-b8e130f3b49d	1	2022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
76420-223	RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE [ASCLEMED USA, INC.]	1	Current NDC, Legacy NDC, 3 package rows	20220710_9881dbb2-1ce2-4737-989f-b26720791ca5.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 · 11 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
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	REMEDYREPACK INC.	0e2e00fa-c4c5-4de7-adf9-cd9786b97016	2026-04-06	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
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 (package): 76420-223-60 ndc (product): 76420-223 ndc11 (package): 76420022360
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

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	9881dbb2-1ce2-4737-989f-b26720791ca5	1
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	9881dbb2-1ce2-4737-989f-b26720791ca5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
76420-223-60	76420022360	60 TABLET, DELAYED RELEASE in 1 BOTTLE (76420-223-60)	2022-07-07	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	2022-07-07	HUMAN PRESCRIPTION DRUG LABEL	1