Protonix

Product NDC: 0008-0843
11-digit product format: 000080843
Labeler code: 0008
Product ID: 0008-0843_b1adaee5-9353-48ce-bde4-f169a3787e30
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: PANTOPRAZOLE SODIUM
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application: NDA020987
Marketing category: NDA
Marketing start: 2000-05-01
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: 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
N020987-001	PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02
N020987-002	PROTONIX	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020987-001	AB
N020987-002	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	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020987-001	PROTONIX	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD, RS	2000-02-02	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020987-002	PROTONIX	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	RLD	2001-06-12	`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	N020987-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N020987-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020987-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020987-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N020987-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020987-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020987-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020987-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020987-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020987-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020987-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020987-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N020987-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020987-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020987-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020987-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020987-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N020987-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020987-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020987-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020987-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020987-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020987-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020987-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020987-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020987-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020987-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020987-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020987-002	AB	1	`782e0a99824c…`

Additional Listing Data#

Finished product: Yes
Brand name base: Protonix
Brand name suffix: Delayed-Release
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE SODIUM	20 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 · 6 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251872	Internal RxNorm lookup
284400	Internal RxNorm lookup
314200	Internal RxNorm lookup
352125	Internal RxNorm lookup
763306	Internal RxNorm lookup
763308	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
08098cb2-c048-4640-f387-6beec4a38936	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
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0008-0843-81	2024-01-30	C162847	48780-1	1030e364-f951-111a-e063-dadaa90a10e2	These highlights do not include all the information needed to use PROTONIX safely and effectively. See full prescribing information for PROTONIX. PROTONIX (pantoprazole sodium) delayed-release tablets, for oral use PROTONIX (pantoprazole sodium) for delayed-release oral suspension Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0008-0843-81	ProtonixDelayed-Release	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90		48

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0008-0843-81	EA - Each	0008-0843	2881cb02-d98a-4779-baa2-368d68678203	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	26
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [PHYSICIANS TOTAL CARE, INC.]	3
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [STAT RX USA LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0008-0843	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.]	47	Current NDC, Legacy NDC, 1 package rows	20240719_08098cb2-c048-4640-f387-6beec4a38936.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protonix Delayed-Release	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	08098cb2-c048-4640-f387-6beec4a38936	2026-05-18	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020987 application number: NDA020987 ndc (product): 0008-0843

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	08098cb2-c048-4640-f387-6beec4a38936	48
763306	pantoprazole sodium 40 MG Delayed Release Oral Granules	PSN	08098cb2-c048-4640-f387-6beec4a38936	48
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	08098cb2-c048-4640-f387-6beec4a38936	48
352125	Protonix 20 MG Delayed Release Oral Tablet	PSN	08098cb2-c048-4640-f387-6beec4a38936	48
763308	Protonix 40 MG Delayed Release Oral Granules	PSN	08098cb2-c048-4640-f387-6beec4a38936	48
284400	Protonix 40 MG Delayed Release Oral Tablet	PSN	08098cb2-c048-4640-f387-6beec4a38936	48
352125	pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]	SBD	08098cb2-c048-4640-f387-6beec4a38936	48
284400	pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]	SBD	08098cb2-c048-4640-f387-6beec4a38936	48
763308	pantoprazole 40 MG Oral Granules [Protonix]	SBD	08098cb2-c048-4640-f387-6beec4a38936	48
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	08098cb2-c048-4640-f387-6beec4a38936	48
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	08098cb2-c048-4640-f387-6beec4a38936	48
763306	pantoprazole 40 MG Oral Granules	SCD	08098cb2-c048-4640-f387-6beec4a38936	48
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
763306	pantoprazole 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules	SY	08098cb2-c048-4640-f387-6beec4a38936	48
763306	pantoprazole 40 MG Enteric Coated Oral Granules for Oral Suspension	SY	08098cb2-c048-4640-f387-6beec4a38936	48
352125	Protonix 20 MG Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
284400	Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
763308	Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Oral Granules	SY	08098cb2-c048-4640-f387-6beec4a38936	48
284400	Protonix 40 MG Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
763308	Protonix 40 MG Enteric Coated Oral Granules for Oral Suspension	SY	08098cb2-c048-4640-f387-6beec4a38936	48
763308	Protonix 40 MG Oral Granules	SY	08098cb2-c048-4640-f387-6beec4a38936	48
352125	Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	08098cb2-c048-4640-f387-6beec4a38936	48
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
352125	Protonix 20 MG Delayed Release Oral Tablet	PSN	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
284400	Protonix 40 MG Delayed Release Oral Tablet	PSN	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
352125	pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]	SBD	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
284400	pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]	SBD	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
352125	Protonix 20 MG Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
284400	Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
284400	Protonix 40 MG Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
352125	Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	72f82e7c-fdfb-4d54-8161-944ba00b700e	3
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	e6238767-90da-4176-8ac6-d71c2025dcb5	1
352125	Protonix 20 MG Delayed Release Oral Tablet	PSN	e6238767-90da-4176-8ac6-d71c2025dcb5	1
352125	pantoprazole 20 MG Delayed Release Oral Tablet [Protonix]	SBD	e6238767-90da-4176-8ac6-d71c2025dcb5	1
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	e6238767-90da-4176-8ac6-d71c2025dcb5	1
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	e6238767-90da-4176-8ac6-d71c2025dcb5	1
352125	Protonix 20 MG Delayed Release Oral Tablet	SY	e6238767-90da-4176-8ac6-d71c2025dcb5	1
352125	Protonx 20 MG (pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	e6238767-90da-4176-8ac6-d71c2025dcb5	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
0008-0843-81	00008084381	90 TABLET, DELAYED RELEASE in 1 BOTTLE (0008-0843-81)	2000-05-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Protonix Delayed-Release	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| AndersonBrecon Inc. \| Takeda GmbH	2026-05-18	HUMAN PRESCRIPTION DRUG LABEL	48
Protonix Delayed-Release	Physicians Total Care, Inc.	2011-12-21	HUMAN PRESCRIPTION DRUG LABEL	3
PROTONIX DELAYED-RELEASE	STAT RX USA LLC	2011-06-22	HUMAN PRESCRIPTION DRUG LABEL	1