rabeprazole sodium delayed-release

Product NDC: 72834-210
11-digit product format: 728340210
Labeler code: 72834
Product ID: 72834-210_f6acf9b5-a111-42b0-acbd-469ab96dd2f9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rabeprazole sodium
Dosage form: CAPSULE, DELAYED RELEASE
Route: ORAL
Labeler: Sarras Health, LLC
Application: NDA204736
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-06-27
Marketing end: 0000-00-00
Substance: RABEPRAZOLE SODIUM
Active strength: 10 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	72834-210		I	Inactivated by FDA		2026-08-17
excluded package	package	72834-210	72834-210-30	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	72834-210-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	72834-210-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	72834-210-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	72834-210-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	72834-210-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	72834-210-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	72834-210-30	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	72834-210-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	72834-210-30	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	72834-210-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	72834-210-30	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	72834-210-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	72834-210-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	72834-210-30	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	72834-210-30	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	72834-210-30	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	72834-210-30	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	72834-210-30	`bd6a592717d7…`	`303034d00443…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N204736-001	ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	5MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-03-26
N204736-002	ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	10MG	CAPSULE, DELAYED RELEASE / ORAL		RLD	2013-03-26

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 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD, RS	2013-03-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
72834-210-30	2022-01-28	C162847	48780-1	d6a99b3a-016d-a426-e053-dadaa90af4c2	These highlights do not include all the information needed to use RABEPRAZOLE SODIUM DELAYED-RELEASE CAPSULES safely and effectively. See full prescribing information for RABEPRAZOLE SODIUM DELAYED-RELEASE CAPSULES. Rabeprazole Sodium Delayed-Release Capsules (Sprinkle), for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72834-210-30	rabeprazole sodium delayed-release	30 in 1 BOTTLE, PLASTIC	CAPSULE, DELAYED RELEASE	30		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72834-210-30	EA - Each	72834-210	ed8c4605-a3a9-447d-8fa3-fbbdad974d3c	1	2019-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72834-210	RABEPRAZOLE SODIUM DELAYED-RELEASE (RABEPRAZOLE SODIUM) CAPSULE, DELAYED RELEASE [SARRAS HEALTH, LLC]	3	Legacy NDC, 1 package rows	20201230_5b1b1530-abc8-487a-b673-2b35cbf14e0c.zip

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
1483318	RABEprazole sodium 10 MG Delayed Release Oral Granules	PSN	5b1b1530-abc8-487a-b673-2b35cbf14e0c	3
1483318	rabeprazole sodium 10 MG Oral Granules	SCD	5b1b1530-abc8-487a-b673-2b35cbf14e0c	3
1483318	rabeprazole sodium 10 MG Delayed Release Oral Sprinkle Capsule	SY	5b1b1530-abc8-487a-b673-2b35cbf14e0c	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
72834-210-30	72834021030	30 CAPSULE, DELAYED RELEASE in 1 BOTTLE, PLASTIC (72834-210-30)	2019-06-27	0000-00-00	No	No	Current