Pantoprazole sodium delayed-release

Product NDC: 70756-018
11-digit product format: 707560018
Labeler code: 70756
Product ID: 70756-018_2c507c43-c033-4b6e-b954-f0f2fb617289
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole sodium delayed-release
Dosage form: TABLET
Route: ORAL
Labeler: Lifestar Pharma LLC
Application: ANDA215880
Marketing category: ANDA
Marketing start: 2024-04-25
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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215880-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2022-07-26
A215880-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2024-04-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215880-001	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 2 · 46 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
2026-09-14 22:38:34	2026-08	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2024-04-25	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215880-002	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2024-04-25	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215880-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2022-07-26	`053a50430f4f…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215880-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215880-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215880-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215880-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215880-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215880-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215880-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215880-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215880-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215880-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215880-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215880-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215880-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A215880-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215880-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215880-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215880-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215880-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215880-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215880-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215880-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A215880-002	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215880-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215880-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215880-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215880-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215880-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215880-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215880-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215880-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215880-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215880-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215880-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215880-001	AB	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215880-001	AB	1	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Pantoprazole sodium delayed-release
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251872	Internal RxNorm lookup
314200	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
0502f935-af7a-4f1e-8c3e-29e20647c885	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
70756-018-51	Pantoprazole sodium delayed-release	500 in 1 BOTTLE	TABLET	500		11
70756-018-90	Pantoprazole sodium delayed-release	90 in 1 BOTTLE	TABLET	90		11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
70756-018	PANTOPRAZOLE SODIUM DELAYED-RELEASE TABLET [LIFESTAR PHARMA LLC]	10	Current NDC, 2 package rows	20240503_0502f935-af7a-4f1e-8c3e-29e20647c885.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
Pantoprazole sodium delayed-release	PANTOPRAZOLE SODIUM DELAYED-RELEASE	Lifestar Pharma LLC	0502f935-af7a-4f1e-8c3e-29e20647c885	2025-09-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215880 application number: ANDA215880 ndc (product): 70756-018

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	0502f935-af7a-4f1e-8c3e-29e20647c885	11
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	0502f935-af7a-4f1e-8c3e-29e20647c885	11
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	0502f935-af7a-4f1e-8c3e-29e20647c885	11
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	0502f935-af7a-4f1e-8c3e-29e20647c885	11
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	0502f935-af7a-4f1e-8c3e-29e20647c885	11
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	0502f935-af7a-4f1e-8c3e-29e20647c885	11

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
70756-018-51	70756001851	500 TABLET in 1 BOTTLE (70756-018-51)	500 tablet	2024-04-25	No	No	Current
70756-018-90	70756001890	90 TABLET in 1 BOTTLE (70756-018-90)	90 tablet	2024-04-25	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole sodium delayed-release	Lifestar Pharma LLC \| Mankind Pharma Limited	2025-09-08	HUMAN PRESCRIPTION DRUG LABEL	11