Pantoprazole Sodium

Product NDC: 63739-564
11-digit product format: 637390564
Labeler code: 63739
Product ID: 63739-564_b5f7a2e5-a205-0aca-e053-2995a90a1747
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: McKesson Corporation dba SKY Packaging
Application: ANDA078281
Marketing category: ANDA
Marketing start: 2011-01-20
Marketing end: 0000-00-00
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: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	63739-564		D	Discontinued by firm		2026-08-17
excluded package	package	63739-564	63739-564-10	D	Discontinued by firm		2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A078281-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-20
A078281-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078281-001	AB
A078281-002	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 · 84 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
2026-08-18 06:07:40	2026-07	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A078281-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078281-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078281-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078281-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078281-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078281-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078281-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078281-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078281-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078281-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078281-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078281-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078281-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A078281-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A078281-002	AB	1	`bb7c543d1eb4…`

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
63739-564-10	2020-07-22	C162847	48780-1	ab0e2407-3391-f274-e053-dbdaa90a6471	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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
63739-564-10	EA - Each	63739-564	8a625c23-8b75-4c6e-9ce9-68caf8f963c7	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
crospovidone	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
glyceryl dibehenate	INACTIVE INGREDIENT	R8WTH25YS2	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
talc	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON PACKAGING SERVICES A BUSINESS UNIT OF MCKESSON CORPORATION]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
63739-564	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MCKESSON CORPORATION DBA SKY PACKAGING]	17	Legacy NDC	20250308_a0141135-3f83-49ba-b50c-31f353bf42f4.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	dcac4022-fea1-67c5-3331-fefcc3c440d8	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	410d5577-e50a-44f3-aaa8-fbf391a0c261	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Chartwell RX, LLC	42a969c3-1144-4151-9cf3-3e9bace6a380	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	b9fa8381-b75e-b1cd-e053-2a95a90a9883	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	PD-Rx Pharmaceuticals, Inc.	b422c5eb-9a6d-4f8c-863d-ca515ec780c2	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aphena Pharma Solutions - Tennessee, LLC	c9bc288b-e84c-4e31-a769-c87a59226086	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	3e5421ef-0875-4a04-b17d-95cca0052c83	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Golden State Medical Supply, Inc.	d6aae78e-308b-7072-e053-2a95a90aaa10	2024-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Lannett Company, Inc.	e7705bf6-e473-4b9c-bb5d-57e26ffe7b97	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Proficient Rx LP	a03aa46f-9eb5-4cf4-addf-745d94af8261	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
63739-564-10	63739056410	10 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-564-10) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK	10 blister pack	2011-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium	McKesson Corporation dba SKY Packaging \| Legacy Pharmaceutical Packaging, LLC	2025-03-05	HUMAN PRESCRIPTION DRUG LABEL	17