Application 204736

Type: NDA
Sponsor: AYTU

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	CAPSULE, DELAYED RELEASE;ORAL	5MG	Yes	No
002	ACIPHEX SPRINKLE	RABEPRAZOLE SODIUM	CAPSULE, DELAYED RELEASE;ORAL	10MG	Yes	Yes

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…`

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 2 · 36 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	0e2e00fa-c4c5-4de7-adf9-cd9786b97016	2026-08-04	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	REMEDYREPACK INC.	63e0b7ca-6b2d-42a9-b9d4-4523b8a20425	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole sodium	RABEPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	04e88b86-e1dd-4c56-8359-45fbcc161f7d	2026-07-27	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	9237eaa4-8eec-fb2a-e053-2995a90ab6c0	2026-06-26	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	c212c9d5-32d3-3c5f-e053-2a95a90af88b	2026-06-02	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	4e8b9858-23a1-4363-b26f-ee6b9ff7ebf9	2026-05-15	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	68b7a793-f22b-4609-a640-94fdec703d93	2026-05-01	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bdad0b58-495e-2352-e053-2a95a90a3198	2026-03-26	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium DR	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b354053c-cb83-79c6-e053-2a95a90afdbe	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	350c20b0-1879-d4cb-e063-6294a90a37f2	2026-03-13	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	3b6a25c2-fb61-4c86-9988-c6ffac7939c4	2026-02-14	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Aciphex	RABEPRAZOLE SODIUM	Waylis Therapeutics LLC	1eb38279-0237-4967-be7a-c53a826c1138	2026-01-27	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advagen Pharma Limited	b1a12c83-74ab-febc-e053-2a95a90a1441	2026-01-13	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Chartwell RX, LLC	c5c43222-d167-4152-b5c7-84b55920a7ce	2025-12-11	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	1855ccab-c377-4962-9225-3c5adc62e2bd	2025-12-08	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals, Inc.	ac9266ed-a9b2-4e77-8607-393b5dcdd2b6	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	4582d443-f1be-4f94-85da-49aa603f54e4	2025-09-17	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	PHOENIX RX LLC	3a674849-b2f6-5f43-e063-6294a90a9e20	2025-07-21	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	DIRECT RX	b1b7def0-834f-37f5-e053-2a95a90ade1f	2025-01-17	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	0863f340-4c7e-379a-e063-6394a90a758d	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23594-205	AcipHex	rabeprazole sodium	Cerecor, Inc.	NDA	Current
23594-205	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-205	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-205	AcipHex	rabeprazole sodium	Cerecor, Inc.	NDA	Current
23594-205	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-205	AcipHex	rabeprazole sodium	Zylera Pharmaceuticals, L	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Cerecor, Inc.	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Cerecor, Inc.	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Aytu Therapeutics, LLC	NDA	Current
23594-210	AcipHex	rabeprazole sodium	Zylera Pharmaceuticals, L	NDA	Current
72834-210	rabeprazole sodium delayed-release	rabeprazole sodium	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current
72834-210	rabeprazole sodium delayed-release	rabeprazole sodium	Sarras Health, LLC	NDA AUTHORIZED GENERIC	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
65429	SUPPL	2020-12-01
65372	SUPPL	2020-11-30
65371	SUPPL	2020-11-30
54580	SUPPL	2018-06-14
54520	SUPPL	2018-06-11
54519	SUPPL	2018-06-11
49135	SUPPL	2017-07-28
49121	SUPPL	2017-07-28
45644	SUPPL	2016-10-26
32585	SUPPL	2016-04-06
19591	SUPPL	2016-04-05
40419	SUPPL	2014-12-29
32587	SUPPL	2014-12-24
32586	SUPPL	2014-10-21
40418	SUPPL	2014-10-16
43476	ORIG	2013-12-06
40417	ORIG	2013-04-01
10385	ORIG	2013-03-28
51632	ORIG	1900-01-01
51631	ORIG	1900-01-01
51630	ORIG	1900-01-01