PANTOPRAZOLE SODIUM

Product NDC: 72603-317
11-digit product format: 726030317
Labeler code: 72603
Product ID: 72603-317_4494f9d0-a1c8-477f-9b4a-f65d7637d9ec
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PANTOPRAZOLE SODIUM
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: NorthStar RxLLC
Application: ANDA213725
Marketing category: ANDA
Marketing start: 2024-10-01
Substance: PANTOPRAZOLE SODIUM
Active strength: 40 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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A213725-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB		2020-06-30

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A213725-001	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.

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	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213725-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	2020-06-30	`a50c72e98297…`

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	A213725-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A213725-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A213725-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A213725-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A213725-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A213725-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A213725-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A213725-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A213725-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A213725-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A213725-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A213725-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A213725-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A213725-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A213725-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A213725-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A213725-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A213725-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A213725-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A213725-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A213725-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213725-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213725-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213725-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213725-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A213725-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A213725-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A213725-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A213725-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A213725-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A213725-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A213725-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A213725-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A213725-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A213725-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A213725-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A213725-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A213725-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A213725-001	AB	1	`a50c72e98297…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2021-12-28 21:50 UTC	2021-12	A213725-001	PC	2021-02-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A213725-001	PC	2021-02-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A213725-001	PC	2021-02-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A213725-001	PC	2021-02-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A213725-001	PC	2021-02-09	`c0c555d07b60…`

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
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE SODIUM	40 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
763306	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
4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	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
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4	Product name	1	20230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
72603-317-01	PANTOPRAZOLE SODIUM	1 in 1 PACKET	GRANULE, DELAYED RELEASE	1		1
72603-317-30	PANTOPRAZOLE SODIUM	30 in 1 CARTON	GRANULE, DELAYED RELEASE	30		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
72603-317-01	EA - Each	72603-317	33e0c50f-7796-4d8b-a334-0e13619a126f	1	2024-12-10
72603-317-30	EA - Each	72603-317	2f4faed7-525c-4a8a-b1fe-e1bb396b3fc9	1	2024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
72603-317	PANTOPRAZOLE SODIUM GRANULE, DELAYED RELEASE [NORTHSTAR RXLLC]	1	Current NDC, 2 package rows	20241001_4494f9d0-a1c8-477f-9b4a-f65d7637d9ec.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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	NorthStar RxLLC	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	2024-08-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213725 application number: ANDA213725 ndc (product): 72603-317
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	Sun Pharmaceutical Industries, Inc.	38353b9e-63bd-47e8-b7cb-b198d1e901f9	2023-08-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 213725 application number: ANDA213725

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
763306	pantoprazole sodium 40 MG Delayed Release Oral Granules	PSN	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	1
763306	pantoprazole 40 MG Oral Granules	SCD	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	1
763306	pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules	SY	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	1
763306	pantoprazole 40 MG Enteric Coated Oral Granules for Oral Suspension	SY	4494f9d0-a1c8-477f-9b4a-f65d7637d9ec	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
72603-317-01	72603031701	1 in 1 PACKET					Historical
72603-317-30	72603031730	30 PACKET in 1 CARTON (72603-317-30) / 1 GRANULE, DELAYED RELEASE in 1 PACKET (72603-317-01)	30 packet	2024-10-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PANTOPRAZOLE SODIUM	NorthStar RxLLC \| Sun Pharmaceutical Industries Limited	2024-08-14	Human Prescription Drug Label	1