AcipHex

Product NDC: 68151-3834
11-digit product format: 681513834
Labeler code: 68151
Product ID: 68151-3834_68239683-18b4-45e0-b132-db401924df17
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: rabeprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Carilion Materials Management
Application: NDA020973
Marketing category: NDA
Marketing start: 1999-08-19
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: E
Listing certified through: 2018-12-31
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	68151-3834		I	Inactivated by FDA		2026-08-07
excluded package	package	68151-3834	68151-3834-3	I	Inactivated by FDA		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 · 44 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		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	68151-3834-3	I	Inactivated by FDA	`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	68151-3834-3	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	68151-3834-3	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	68151-3834-3	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	68151-3834-3	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	68151-3834-3	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	68151-3834-3	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	68151-3834-3	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	68151-3834-3	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	68151-3834-3	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	68151-3834-3	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	68151-3834-3	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	68151-3834-3	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	68151-3834-3	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	68151-3834-3	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	68151-3834-3	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	68151-3834-3	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	68151-3834-3	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	68151-3834-3	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	68151-3834-3	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	68151-3834-3	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	68151-3834-3	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68151-3834-3	2020-01-31	C162847	48780-1	9d75b9d1-27a2-f424-e053-dadaa90a57ce	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 . A CIPHEX ® (rabeprazole sodium) d elayed - r elease t ablets , 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
68151-3834-3	AcipHex	1 in 1 PACKAGE	TABLET, DELAYED RELEASE	1		3

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
RABEPRAZOLE SODIUM	ACTIVE INGREDIENT	3L36P16U4R	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
RABEPRAZOLE	ACTIVE MOIETY	32828355LL	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
ETHYLCELLULOSES	INACTIVE INGREDIENT	7Z8S9VYZ4B	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
HYPROMELLOSE PHTHALATE (24% PHTHALATE, 55 CST)	INACTIVE INGREDIENT	87Y6436BKR	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
SODIUM STEARYL FUMARATE	INACTIVE INGREDIENT	7CV7WJK4UI	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68151-3834	ACIPHEX (RABEPRAZOLE SODIUM) TABLET, DELAYED RELEASE [CARILION MATERIALS MANAGEMENT]	3	Legacy NDC, 1 package rows	20160806_001dd372-2692-4d6f-a71c-95e7056349a9.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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
854870	AcipHex 20 MG Delayed Release Oral Tablet	PSN	001dd372-2692-4d6f-a71c-95e7056349a9	3
854868	RABEprazole sodium 20 MG Delayed Release Oral Tablet	PSN	001dd372-2692-4d6f-a71c-95e7056349a9	3
854870	rabeprazole sodium 20 MG Delayed Release Oral Tablet [Aciphex]	SBD	001dd372-2692-4d6f-a71c-95e7056349a9	3
854868	rabeprazole sodium 20 MG Delayed Release Oral Tablet	SCD	001dd372-2692-4d6f-a71c-95e7056349a9	3
854870	Aciphex 20 MG Delayed Release Oral Tablet	SY	001dd372-2692-4d6f-a71c-95e7056349a9	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
68151-3834-3	68151383403	1 in 1 PACKAGE	Historical