Pantoprazole Sodium

Product NDC: 80425-0162
11-digit product format: 804250162
Labeler code: 80425
Product ID: 80425-0162_2a99a670-af2e-299d-e063-6294a90a05d2
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Advanced Rx Pharmacy of Tennessee, LLC
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: 2026-12-31
Current FDA listing: Yes

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
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 · 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	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`caaa826d4ba7…`
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…`

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	A202882-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A202882-002	AB	1	`caaa826d4ba7…`
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…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pantoprazole Sodium
Brand name suffix: DR
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
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
c89a5396-1d94-c7fa-e053-2995a90a9063	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	SPL version
80425-0162-1	Pantoprazole SodiumDR	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	9
80425-0162-2	Pantoprazole SodiumDR	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	9
80425-0162-3	Pantoprazole SodiumDR	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
80425-0162-1	EA - Each	80425-0162	bc5343da-0a00-4ea9-9231-7f4d25ef8301	1	2023-04-07
80425-0162-2	EA - Each	80425-0162	ed292429-426e-459e-90f1-c83a3d68774e	1	2023-04-07
80425-0162-3	EA - Each	80425-0162	d544793e-3841-4115-bf5f-a348d9c44e23	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
80425-0162	PANTOPRAZOLE SODIUM DR (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]	9	Current NDC, Legacy NDC, 3 package rows	20250101_c89a5396-1d94-c7fa-e053-2995a90a9063.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	Preferred Pharmaceuticals Inc.	5c14e2f3-625d-4089-a404-440b0ecf72e7	2026-08-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
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
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	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 ndc (product): 80425-0162
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

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	c89a5396-1d94-c7fa-e053-2995a90a9063	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
80425-0162-1	80425016201	30 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-1)	2014-09-10	0000-00-00	No	No	Current
80425-0162-2	80425016202	60 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-2)	2014-09-10	0000-00-00	No	No	Current
80425-0162-3	80425016203	90 TABLET, DELAYED RELEASE in 1 BOTTLE (80425-0162-3)	2014-09-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium DR Tablets	Advanced Rx Pharmacy of Tennessee, LLC	2024-12-31	HUMAN PRESCRIPTION DRUG LABEL	9