Aciphex

Product NDC: 69784-243
11-digit product format: 697840243
Labeler code: 69784
Product ID: 69784-243_be3a78bc-4f9c-473f-bb62-bd1d6920b5ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Woodward Pharma Services LLC
Application: NDA020973
Marketing category: NDA
Marketing start: 2022-05-15
Marketing end: 0000-00-00
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: 2023-12-31
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	69784-243		D	Discontinued by firm		2026-08-07
excluded package	package	69784-243	69784-243-30	D	Discontinued by firm		2026-08-07

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 · 18 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69784-243-30	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69784-243-30	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69784-243-30	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69784-243-30	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69784-243-30	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69784-243-30	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69784-243-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69784-243-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69784-243-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N020973-001	ACIPHEX	RABEPRAZOLE SODIUM	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29
N020973-002	ACIPHEX	RABEPRAZOLE SODIUM	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020973-002	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 3 · 82 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020973-001	ACIPHEX	10MG Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020973-002	ACIPHEX	20MG	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	1999-08-19	`782e0a99824c…`

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	N020973-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020973-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020973-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020973-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020973-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020973-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020973-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020973-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020973-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020973-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020973-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020973-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020973-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020973-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020973-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020973-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020973-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020973-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020973-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020973-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020973-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020973-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020973-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020973-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020973-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020973-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020973-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020973-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020973-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020973-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020973-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020973-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020973-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020973-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020973-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020973-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020973-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020973-002	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020973-002	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020973-002	AB	1	`cb3db0bc1861…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69784-243-30	2025-09-18	C162847	48780-1	2cef2736-a322-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ACIPHEX DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for ACIPHEX DELAYED-RELEASE TABLETS. ACIPHEX ® (rabeprazole sodium) delayed-release tablets, for oral use Initial U.S. Approval: 1999
69784-243-30	2025-01-30	C162847	48780-1	2cef2736-a322-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use ACIPHEX DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for ACIPHEX DELAYED-RELEASE TABLETS. ACIPHEX ® (rabeprazole sodium) delayed-release tablets, for oral use Initial U.S. Approval: 1999

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
69784-243-30	EA - Each	69784-243	5d710f83-30a8-4a82-82e8-69e77fdd2dc9	1	2022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69784-243	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [WOODWARD PHARMA SERVICES LLC]	1	Legacy NDC	20220520_42282e11-3179-420e-b979-e53dd5bd4b12.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aciphex	RABEPRAZOLE SODIUM	Waylis Therapeutics LLC	1eb38279-0237-4967-be7a-c53a826c1138	2026-01-27	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020973 application number: NDA020973

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
3L36P16U4R	RABEPRAZOLE SODIUM	117976-90-6	RABEPRAZOLE SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69784-243-30	69784024330	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (69784-243-30)	2022-05-15	0000-00-00	No	No	Current