Pantoprazole Sodium

Product NDC: 71335-1165
Requested package NDC: 71335-1165-5
11-digit product format: 713351165
Labeler code: 71335
Product ID: 71335-1165_aeabd7ab-9ae8-4fbf-af5e-deaf166965b9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA202038
Marketing category: ANDA
Marketing start: 2012-09-28
Substance: PANTOPRAZOLE SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	71335-1165	71335-1165-5	D	Discontinued by firm		2026-08-03

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 · 14 matching rows.

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

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	D	Discontinued by firm	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	D	Discontinued by firm	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	D	Discontinued by firm	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	D	Discontinued by firm	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	D	Discontinued by firm	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	D	Discontinued by firm	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	D	Discontinued by firm	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	D	Discontinued by firm	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	D	Discontinued by firm	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	D	Discontinued by firm	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

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
A202038-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-09-28
A202038-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-09-28

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A202038-001	AB
A202038-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`782e0a99824c…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 82 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	A202038-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202038-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202038-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202038-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202038-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202038-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202038-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202038-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202038-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202038-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202038-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202038-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202038-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202038-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202038-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202038-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202038-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202038-002	AB	1	`782e0a99824c…`

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE 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
6871619Q5X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251872	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
03dea010-4bae-43ab-893e-9bbddb58062d	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041	Product name	8	20260304
41d62193-73fc-49cf-9907-add9588e2da1	Product name	9	20260112
f12d0d0d-c068-46c6-872c-96c9d38533bb	Product name	1	20250116
6c13b22c-b3ba-4127-b768-0132dd5ab0d1	Product name	1	20230829
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
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, Related label table
NDC	Effective	Related label
71335-1165-1	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-1	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-2	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-2	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-3	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-3	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-4	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-4	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-5	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-5	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-6	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-6	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-7	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-7	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-8	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-8	2024-05-20	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-1	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-1	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-2	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-2	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-3	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-3	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-4	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-4	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-5	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-5	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-6	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-6	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-7	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-7	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-8	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000
71335-1165-8	2024-01-30	These highlights do not include all the information needed to use PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS safely and effectively. See full prescribing information for PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLETS. PANTOPRAZOLE SODIUM delayed-release tablets, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71335-1165-1	Pantoprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	102
71335-1165-2	Pantoprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	102
71335-1165-3	Pantoprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	102
71335-1165-4	Pantoprazole Sodium	56 in 1 BOTTLE	TABLET, DELAYED RELEASE	56	102
71335-1165-5	Pantoprazole Sodium	28 in 1 BOTTLE	TABLET, DELAYED RELEASE	28	102
71335-1165-6	Pantoprazole Sodium	10 in 1 BOTTLE	TABLET, DELAYED RELEASE	10	102
71335-1165-7	Pantoprazole Sodium	120 in 1 BOTTLE	TABLET, DELAYED RELEASE	120	102
71335-1165-8	Pantoprazole Sodium	180 in 1 BOTTLE	TABLET, DELAYED RELEASE	180	102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71335-1165-1	EA - Each	71335-1165	deb6d8f5-d618-440a-a345-988719ef96d4	1	2019-08-06
71335-1165-2	EA - Each	71335-1165	feec12fa-652a-4b27-936c-fcf041a88934	1	2019-08-06
71335-1165-3	EA - Each	71335-1165	755d1378-00f3-40d1-8f77-3c2cc11612c0	1	2019-08-06
71335-1165-4	EA - Each	71335-1165	abd22035-9eea-4eda-99c0-2e4b09378254	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71335-1165	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]	102	Current NDC, Legacy NDC, 8 package rows	20240522_03dea010-4bae-43ab-893e-9bbddb58062d.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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	76e1839b-7462-4344-b319-001a5f57d67a	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f38a6df2-1dd4-48bf-9ec4-1113ce492e78	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	558dc7e1-dfd5-d3d7-e063-6394a90ab9c3	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f313159c-115a-4cf6-b32e-9ddc833fd51c	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	5566b4b1-b4f5-4020-e063-6394a90a5257	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	HAWAII REPACK, INC.	f403c94d-68b7-43df-8c8e-c9fef3309cfc	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	03dea010-4bae-43ab-893e-9bbddb58062d	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038 ndc (package): 71335-1165-5 ndc (product): 71335-1165 ndc11 (package): 71335116505
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	5331f534-4724-52e8-e063-6394a90aa548	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	52bbab54-9f11-77bc-e063-6394a90ab449	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	9a1159d3-b9fa-4026-962c-d3001002e610	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	QPharma Inc	0e200326-8885-18d0-e063-6294a90aad2f	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aurobindo Pharma Limited	7418f358-f536-4de6-adf0-562b4373f2e3	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NorthStar Rx LLC	6637d90b-b268-4a5f-ab5b-885f2d5f0d4b	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Burel Pharmaceuticals, LLC	3cc5197e-6b39-4415-b963-d4bbeecd7953	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	6229247e-ee15-466e-a8ac-adcd646b738d	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Major Pharmaceuticals	de419aa0-caa9-40fb-bc6d-e341c94273c7	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	f2a1af50-a051-3e55-e053-2a95a90a9184	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	d9deb251-96d3-5f96-e053-2a95a90a0792	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	8aac1642-6cb0-6ad2-e053-2a95a90a4cbd	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Quality Care Products, LLC	a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6871619Q5X	PANTOPRAZOLE SODIUM	164579-32-2	PANTOPRAZOLE SODIUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	03dea010-4bae-43ab-893e-9bbddb58062d	102
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	03dea010-4bae-43ab-893e-9bbddb58062d	102
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	03dea010-4bae-43ab-893e-9bbddb58062d	102

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
71335-1165-5	71335116505	28 TABLET, DELAYED RELEASE in 1 BOTTLE (71335-1165-5)	2024-05-17	0000-00-00	No	No	Current