PANTOPRAZOLE SODIUM

Product NDC: 31722-713
Requested package NDC: 31722-713-10
11-digit product format: 317220713
Labeler code: 31722
Product ID: 31722-713_48f42a12-2eac-e5dd-e063-6294a90aa92d
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PANTOPRAZOLE
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Camber Pharmaceuticals, Inc.
Application: ANDA202882
Marketing category: ANDA
Marketing start: 2014-09-10
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: 2027-12-31
Current FDA listing: Yes

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
A202882-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2014-09-10
A202882-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2014-09-10

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202882-001	AB
A202882-002	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	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`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	A202882-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202882-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202882-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202882-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202882-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202882-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202882-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202882-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202882-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202882-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202882-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202882-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202882-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202882-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202882-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202882-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202882-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202882-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202882-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202882-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202882-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202882-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202882-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202882-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202882-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202882-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202882-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202882-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202882-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202882-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202882-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202882-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202882-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202882-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202882-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202882-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202882-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202882-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202882-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202882-002	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	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 · 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
9daa1483-5a36-44db-9e0d-904d100da262	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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
31722-713-10	2021-02-19	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
31722-713-31	2021-02-19	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
31722-713-32	2021-02-19	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
31722-713-90	2021-02-19	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
31722-713-10	2021-01-29	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
31722-713-31	2021-01-29	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
31722-713-32	2021-01-29	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
31722-713-90	2021-01-29	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
31722-713-10	PANTOPRAZOLE SODIUM	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	14
31722-713-31	PANTOPRAZOLE SODIUM	10 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	10	14
31722-713-32	PANTOPRAZOLE SODIUM	10 in 1 CARTON	TABLET, DELAYED RELEASE	10	14
31722-713-90	PANTOPRAZOLE SODIUM	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
31722-713-10	EA - Each	31722-713	4edcc0af-d5ce-4c89-b424-a2fb40520df5	1	2020-03-10
31722-713-90	EA - Each	31722-713	36f3ef4a-c43e-4514-a1f8-87278d26c57e	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
HYDROXYPROPYL CELLULOSE (Type H)	INACTIVE INGREDIENT	RFW2ET671P	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
31722-713	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [CAMBER PHARMACEUTICALS, INC.]	13	Current NDC, Legacy NDC, 4 package rows	20240203_9daa1483-5a36-44db-9e0d-904d100da262.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 · 28 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Sportpharm LLC	b58c376e-616b-4970-a375-52ff630e7f09	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	HAWAII REPACK, INC.	f85e6d64-1ddc-4f4a-86dc-0749081a6a5f	2026-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	St. Mary's Medical Park Pharmacy	e1aa55ec-5e0e-3a58-e053-2a95a90abe4f	2026-06-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Bryant Ranch Prepack	fa8eed8c-f5d0-4b90-b184-cff8d9c8fb6a	2026-05-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM DR	Direct_Rx	0515ceaa-7d17-c92f-e063-6294a90a044e	2026-03-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	PD-Rx Pharmaceuticals, Inc.	c1f37929-a981-4ace-95e6-ae6795a797b3	2026-02-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Camber Pharmaceuticals, Inc.	9daa1483-5a36-44db-9e0d-904d100da262	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882 ndc (package): 31722-713-10 ndc (product): 31722-713 ndc11 (package): 31722071310
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Quallent Pharmaceuticals Health LLC	643eb498-d916-4fb7-9281-32895575ab36	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Northwind Health Company, LLC	da67e1c0-9947-957d-e053-2a95a90ad96d	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	QPharma Inc	b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6	2025-12-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Preferred Pharmaceuticals Inc.	5c14e2f3-625d-4089-a404-440b0ecf72e7	2025-09-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	DIRECT RX	a7e7c1ab-3e75-1ff8-e053-2995a90a7539	2025-01-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	c89a5396-1d94-c7fa-e053-2995a90a9063	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	bd4759ac-46b5-6903-e053-2a95a90a6319	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f5c9e3c6-d4b0-0ebe-e053-2995a90abe55	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	a9f32edf-e0b9-4e96-e053-2a95a90afbc8	2024-10-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	b2abc159-e450-99dc-e053-2a95a90abe6a	2024-07-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Proficient Rx LP	50a278de-bd16-417c-a741-81bfe0d745f2	2024-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	NuCare Pharmaceuticals,Inc.	8748a588-a1e5-9dfc-e053-2a95a90a846c	2024-06-14	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	A-S Medication Solutions	39ba58cc-e4ef-4b82-a0f3-9583fa123a38	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6871619Q5X	PANTOPRAZOLE SODIUM	164579-32-2	PANTOPRAZOLE SODIUM
D8TST4O562	PANTOPRAZOLE	102625-70-7	PANTOPRAZOLE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	c1f37929-a981-4ace-95e6-ae6795a797b3	17
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	c1f37929-a981-4ace-95e6-ae6795a797b3	17
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	c1f37929-a981-4ace-95e6-ae6795a797b3	17
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	617bb464-5357-472f-8e9d-61aae5b2ebef	15
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	617bb464-5357-472f-8e9d-61aae5b2ebef	15
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	617bb464-5357-472f-8e9d-61aae5b2ebef	15
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	9daa1483-5a36-44db-9e0d-904d100da262	14
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	9daa1483-5a36-44db-9e0d-904d100da262	14
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	9daa1483-5a36-44db-9e0d-904d100da262	14
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	9daa1483-5a36-44db-9e0d-904d100da262	14
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	9daa1483-5a36-44db-9e0d-904d100da262	14
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	9daa1483-5a36-44db-9e0d-904d100da262	14
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	bd4759ac-46b5-6903-e053-2a95a90a6319	9
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	c89a5396-1d94-c7fa-e053-2995a90a9063	9
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	bd4759ac-46b5-6903-e053-2a95a90a6319	9
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	c89a5396-1d94-c7fa-e053-2995a90a9063	9
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	c89a5396-1d94-c7fa-e053-2995a90a9063	9
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	bd4759ac-46b5-6903-e053-2a95a90a6319	9
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	3a8fa326-ad75-4b6d-8832-0a2357eeca2f	8
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	3a8fa326-ad75-4b6d-8832-0a2357eeca2f	8
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	3a8fa326-ad75-4b6d-8832-0a2357eeca2f	8
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	a9f32edf-e0b9-4e96-e053-2a95a90afbc8	5
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	50a278de-bd16-417c-a741-81bfe0d745f2	5
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6	5
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	a9f32edf-e0b9-4e96-e053-2a95a90afbc8	5
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	50a278de-bd16-417c-a741-81bfe0d745f2	5
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6	5
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	50a278de-bd16-417c-a741-81bfe0d745f2	5
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	a9f32edf-e0b9-4e96-e053-2a95a90afbc8	5
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	b4a94a37-47c1-4dd9-9e4d-5b4a03480aa6	5
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	8748a588-a1e5-9dfc-e053-2a95a90a846c	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	0515ceaa-7d17-c92f-e063-6294a90a044e	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	0515ceaa-7d17-c92f-e063-6294a90a044e	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	8748a588-a1e5-9dfc-e053-2a95a90a846c	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	8748a588-a1e5-9dfc-e053-2a95a90a846c	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	0515ceaa-7d17-c92f-e063-6294a90a044e	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	6a09187d-0859-471b-a283-836a6494757c	2
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	5c14e2f3-625d-4089-a404-440b0ecf72e7	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	6a09187d-0859-471b-a283-836a6494757c	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	5c14e2f3-625d-4089-a404-440b0ecf72e7	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	5c14e2f3-625d-4089-a404-440b0ecf72e7	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	6a09187d-0859-471b-a283-836a6494757c	2
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	3540d01c-da0e-477e-9e90-994b96deb1d6	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	3540d01c-da0e-477e-9e90-994b96deb1d6	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	e1aa55ec-5e0e-3a58-e053-2a95a90abe4f	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	1495af43-0670-e799-e063-6294a90a82a4	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	2644b0ef-07f0-66b9-e063-6394a90a5fa0	1
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	3540d01c-da0e-477e-9e90-994b96deb1d6	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	e1aa55ec-5e0e-3a58-e053-2a95a90abe4f	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	1495af43-0670-e799-e063-6294a90a82a4	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	2644b0ef-07f0-66b9-e063-6394a90a5fa0	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	3540d01c-da0e-477e-9e90-994b96deb1d6	1
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	3540d01c-da0e-477e-9e90-994b96deb1d6	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	2644b0ef-07f0-66b9-e063-6394a90a5fa0	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	1495af43-0670-e799-e063-6294a90a82a4	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	e1aa55ec-5e0e-3a58-e053-2a95a90abe4f	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	3540d01c-da0e-477e-9e90-994b96deb1d6	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
31722-713-10	31722071310	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (31722-713-10)	2014-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PANTOPRAZOLE SODIUM	Sportpharm LLC	2026-06-29	HUMAN PRESCRIPTION DRUG LABEL	1
PANTOPRAZOLE SODIUM	HAWAII REPACK, INC.	2026-06-27	HUMAN PRESCRIPTION DRUG LABEL	2
PANTOPRAZOLE SODIUM	St. Mary's Medical Park Pharmacy	2026-06-21	HUMAN PRESCRIPTION DRUG LABEL	2
Pantoprazole Sodium DR	Direct_Rx	2026-03-05	HUMAN PRESCRIPTION DRUG LABEL	3
PANTOPRAZOLE SODIUM	PD-Rx Pharmaceuticals, Inc.	2026-02-25	HUMAN PRESCRIPTION DRUG LABEL	17
PANTOPRAZOLE SODIUM	Camber Pharmaceuticals, Inc. \| Hetero Labs Limited Unit V	2026-01-22	HUMAN PRESCRIPTION DRUG LABEL	14
PANTOPRAZOLE SODIUM	Legacy Pharmaceutical Packaging, LLC	2025-12-31	HUMAN PRESCRIPTION DRUG LABEL	15
PANTOPRAZOLE SODIUM	QPharma Inc \| Hetero Labs Limited Unit V \| Northwind Health Company, LLC	2025-12-04	HUMAN PRESCRIPTION DRUG LABEL	5
PANTOPRAZOLE SODIUM	Preferred Pharmaceuticals Inc.	2025-09-05	HUMAN PRESCRIPTION DRUG LABEL	2
Pantoprazole Sodium DR Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	9
Pantoprazole Sodium DR Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	9
PANTOPRAZOLE SODIUM	Quality Care Products, LLC	2024-12-18	Human Prescription Drug Label	11
PANTOPRAZOLE SODIUM	Coupler LLC	2024-11-06	HUMAN PRESCRIPTION DRUG LABEL	1
PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	2024-10-02	HUMAN PRESCRIPTION DRUG LABEL	5
PANTOPRAZOLE SODIUM	Proficient Rx LP	2024-07-01	HUMAN PRESCRIPTION DRUG LABEL	5
PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	2024-06-14	HUMAN PRESCRIPTION DRUG LABEL	3
PANTOPRAZOLE SODIUM	A-S Medication Solutions	2024-04-25	HUMAN PRESCRIPTION DRUG LABEL	8
PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	2024-04-03	HUMAN PRESCRIPTION DRUG LABEL	15
PANTOPRAZOLE SODIUM	Medsource Pharmaceuticals \| Hetero Labs Limited Unit V	2024-03-26	HUMAN PRESCRIPTION DRUG LABEL	1
PANTOPRAZOLE SODIUM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-03-13	HUMAN PRESCRIPTION DRUG LABEL	1
PANTOPRAZOLE SODIUM	RPK Pharmaceuticals, Inc.	2023-06-06	HUMAN PRESCRIPTION DRUG LABEL	2