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 43.

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 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N204736-001	ACIPHEX SPRINKLE	5MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N204736-002	ACIPHEX SPRINKLE	10MG	CAPSULE, DELAYED RELEASE / ORAL	RLD	2013-03-26	`84e616aacf4f…`
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…`

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 2 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	Advanced Rx of Tennessee, LLC	0863f340-4c7e-379a-e063-6394a90a758d	2024-12-31	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	26f8c3bc-4402-e92c-e063-6294a90a9ad7	2024-11-15	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	9ea2552c-873c-4ab2-84b0-dd54e84e4eee	2024-08-21	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	8d8c1a72-b4c4-4699-b9c3-3a39a9df44f2	2024-07-16	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	14412af6-e99c-4264-bc34-28a6f139f252	2024-07-01	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	b35f376a-f2a4-4eb9-80ac-9c20ceb2f0bf	2024-05-20	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Golden State Medical Supply, Inc.	87231460-8b1e-b995-e053-2a91aa0a6c43	2024-04-16	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Aurobindo Pharma Limited	d11c3211-b4d4-4893-8c1c-b8fb6d0a0b89	2024-02-28	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	A-S Medication Solutions	bafff1ac-02fb-4726-b2d7-6e099ae981cb	2023-12-11	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Bryant Ranch Prepack	e6350638-99b0-474d-be75-ae2a3e1af2cf	2023-12-04	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Lannett Company, Inc.	7f7d68f0-972b-4315-b712-0bb8a84c85cc	2023-07-31	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	A-S Medication Solutions	4ded337a-31b8-47c3-b5ab-33a785afb7d8	2023-02-06	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	9881dbb2-1ce2-4737-989f-b26720791ca5	2022-07-07	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
RABEPRAZOLE SODIUM	RABEPRAZOLE SODIUM	Proficient Rx LP	0f5eb1b4-ad4b-4782-8d3d-cd33f9c5be7d	2022-04-01	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole sodium	RABEPRAZOLE SODIUM	Proficient Rx LP	d1444508-fe40-4f68-8350-52f13399e38a	2021-01-01	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM
Rabeprazole Sodium	RABEPRAZOLE SODIUM	Asclemed USA, Inc.	12eaf996-db61-41d6-82e1-fa6196435603	2020-06-26	Warnings, Adverse reactions	Name fallback generic name: RABEPRAZOLE SODIUM

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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