Aciphex

Product NDC: 80725-243
Requested package NDC: 80725-243-30
11-digit product format: 807250243
Labeler code: 80725
Product ID: 80725-243_cc6cb214-ac28-4c8b-9b57-7635ef896038
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Waylis Therapeutics LLC
Application: NDA020973
Marketing category: NDA
Marketing start: 2022-05-15
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: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	80725-243	80725-243-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	80725-243	80725-243-30	U	Excluded because listing certification expired		excluded / ndc_excluded.zip	`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N020973-001	ACIPHEX	RABEPRAZOLE SODIUM	10MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, DELAYED RELEASE / ORAL		RLD	2002-05-29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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Aciphex
Listing expiration: 2027-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
854868	Internal RxNorm lookup
854870	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
1eb38279-0237-4967-be7a-c53a826c1138	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
41e5d082-a3b8-4ff4-92a1-6fdf8d5110b4	Product name	4	20180626
9a0b93b8-7081-4ac2-867c-2955b2d759fd	Product name	2	20170909
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
80725-243-30	Aciphex	30 in 1 BOTTLE, PLASTIC	TABLET, 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
80725-243-30	EA - Each	80725-243	d0eec9f8-544e-4368-9299-1018d4165a2a	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80725-243	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [WAYLIS THERAPEUTICS LLC]	2	Current NDC, 1 package rows	20250129_1eb38279-0237-4967-be7a-c53a826c1138.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 ndc (package): 80725-243-30 ndc (product): 80725-243 ndc11 (package): 80725024330

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
854870	AcipHex 20 MG Delayed Release Oral Tablet	PSN	1eb38279-0237-4967-be7a-c53a826c1138	3
854868	RABEprazole sodium 20 MG Delayed Release Oral Tablet	PSN	1eb38279-0237-4967-be7a-c53a826c1138	3
854870	rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]	SBD	1eb38279-0237-4967-be7a-c53a826c1138	3
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	1eb38279-0237-4967-be7a-c53a826c1138	3
854870	Aciphex 20 MG Delayed Release Oral Tablet	SY	1eb38279-0237-4967-be7a-c53a826c1138	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
80725-243-30	80725024330	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (80725-243-30)	2023-12-01	No	No	Current