Pantoprazole Sodium

Product NDC: 45865-622
Requested package NDC: 45865-622-90
11-digit product format: 458650622
Labeler code: 45865
Product ID: 45865-622_9ab34397-58b8-74c5-e053-2995a90abd86
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Medsource Pharmaceuticals
Application: ANDA077056
Marketing category: ANDA
Marketing start: 2007-12-21
Marketing end: 0000-00-00
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: 2020-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	45865-622	45865-622-90	I	Inactivated by FDA		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 · 9 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	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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
A077056-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL			2007-08-02
A077056-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL			2007-08-02

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	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2007-08-02	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A077056-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A077056-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL		2007-08-02	`782e0a99824c…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A077056-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A077056-002	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A077056-001	AB	1	`3f01610625f2…`
2019-12-14 00:12 UTC	2019-12	A077056-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A077056-001	AB	1	`b00525d2431f…`
2019-09-15 20:21 UTC	2019-09	A077056-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A077056-001	AB	1	`ea99ee380514…`
2019-07-19 19:46 UTC	2019-07	A077056-002	AB	1	`ea99ee380514…`

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, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
45865-622-30	2025-01-30	C162847	48780-1	2cef2736-6d4f-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets USP safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets USP. PANTOPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 2000
45865-622-60	2025-01-30	C162847	48780-1	2cef2736-6d4f-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets USP safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets USP. PANTOPRAZOLE sodium delayed-release tablets, for oral use Initial U.S. Approval: 2000
45865-622-90	2025-01-30	C162847	48780-1	2cef2736-6d4f-d83d-e063-dadaa90ab31f	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets USP safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets USP. 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
45865-622-30	Pantoprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	2
45865-622-60	Pantoprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	2
45865-622-90	Pantoprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
ALUMINUM OXIDE	INACTIVE INGREDIENT	LMI26O6933	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
CALCIUM CARBONATE	INACTIVE INGREDIENT	H0G9379FGK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
D&C YELLOW NO. 10	INACTIVE INGREDIENT	35SW5USQ3G	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
FD&C YELLOW NO. 6	INACTIVE INGREDIENT	H77VEI93A8	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED	INACTIVE INGREDIENT	2165RE0K14	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (15 MPA.S)	INACTIVE INGREDIENT	36SFW2JZ0W	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
45865-622	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MEDSOURCE PHARMACEUTICALS]	2	Legacy NDC, 3 package rows	20191228_1f7fd914-08ee-664e-e054-00144ff88e88.zip

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	1f7fd914-08ee-664e-e054-00144ff88e88	2
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	1f7fd914-08ee-664e-e054-00144ff88e88	2
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	1f7fd914-08ee-664e-e054-00144ff88e88	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
45865-622-90	45865062290	90 TABLET, DELAYED RELEASE in 1 BOTTLE (45865-622-90)	2007-12-21	0000-00-00	No	No	Current