PANTOPRAZOLE SODIUM

Product NDC: 85534-0028
11-digit product format: 855340028
Labeler code: 85534
Product ID: 85534-0028_553e4a15-6652-7588-e063-6294a90a6086
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PANTOPRAZOLE
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: HAWAII REPACK, 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 43.

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 · 86 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
2026-09-14 22:38:34	2026-08	A202882-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202882-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2014-09-10	`84e616aacf4f…`
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…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A202882-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A202882-002	AB	1	`84e616aacf4f…`
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…`

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: 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
f85e6d64-1ddc-4f4a-86dc-0749081a6a5f	Available on FDA.report

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 2 of 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	A-S Medication Solutions	3a8fa326-ad75-4b6d-8832-0a2357eeca2f	2024-04-25	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Bryant Ranch Prepack	617bb464-5357-472f-8e9d-61aae5b2ebef	2024-04-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Asclemed USA, Inc.	3540d01c-da0e-477e-9e90-994b96deb1d6	2024-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Asclemed USA, Inc.	ff15c4f1-8869-4422-9631-dc488e09e583	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	c10e9c12-e39d-4b0b-bd4c-10d3e9a4cf34	2023-02-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	XLCare Pharmaceuticals Inc.	17468dbf-84b6-4c53-9ad5-341350d2cfab	2023-01-17	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Aphena Pharma Solutions - Tennessee, LLC	e3f711d8-b9d3-46a6-8bf9-6af1cc77003e	2022-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202882 application number: ANDA202882
PANTOPRAZOLE SODIUM	PANTOPRAZOLE	Proficient Rx LP	dce2e97a-cd92-46b9-9444-91739bdcd526	2019-11-01	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
85534-0028-0	85534002800	10 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0028-0)	2026-06-25	No	No	Current
85534-0028-1	85534002801	30 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0028-1)	2026-06-25	No	No	Current
85534-0028-2	85534002802	60 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0028-2)	2026-06-25	No	No	Current
85534-0028-3	85534002803	90 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0028-3)	2026-06-25	No	No	Current
85534-0028-4	85534002804	120 TABLET, DELAYED RELEASE in 1 BOTTLE (85534-0028-4)	2026-06-25	No	No	Current