Protonix

Product NDC: 55154-4232
11-digit product format: 551544232
Labeler code: 55154
Product ID: 55154-4232_2fd2b436-0be8-4f80-8554-2f663bc8af80
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pantoprazole sodium
Dosage form: GRANULE, DELAYED RELEASE
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: NDA022020
Marketing category: NDA
Marketing start: 2008-02-29
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: 2023-12-31
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	55154-4232		D	Discontinued by firm		2026-08-11
excluded package	package	55154-4232	55154-4232-0	D	Discontinued by firm		2026-08-11

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product	55154-4232		D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	55154-4232	55154-4232-0	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N022020-001	PROTONIX	PANTOPRAZOLE SODIUM	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022020-001	AB

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-product	Patent	Expiration	Use code	Coverage / status	Submission date
N022020-001	7544370	2026-06-07		Drug product
N022020-001	7544370*PED	2026-12-07		Pediatric extension

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 2 · 41 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	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL		RLD, RS	2007-11-14	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022020-001	PROTONIX	EQ 40MG BASE	FOR SUSPENSION, DELAYED RELEASE / ORAL	AB	RLD, RS	2007-11-14	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022020-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022020-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022020-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022020-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022020-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022020-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022020-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022020-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022020-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022020-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022020-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022020-001	AB	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022020-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022020-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022020-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022020-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022020-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022020-001	AB	1	`c0c555d07b60…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022020-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022020-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022020-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022020-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022020-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022020-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022020-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022020-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022020-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022020-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022020-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022020-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022020-001	AB	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022020-001	AB	1	`a50c72e98297…`

Observed Orange Book patent history#

Patent history page 1 of 8 · 307 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N022020-001	7544370	2026-06-07		Drug product	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7550153	2024-09-30	U-859		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7553498	2024-09-30	U-859		`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7838027	2024-09-30	U-859	Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7544370	2026-06-07		Drug product	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022020-001	7544370	2026-06-07		Drug product	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	7544370	2026-06-07		Drug product	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	7544370	2026-06-07		Drug product	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7550153	2024-09-30	U-859		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7553498	2024-09-30	U-859		`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7838027	2024-09-30	U-859	Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7544370	2026-06-07		Drug product	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022020-001	7544370*PED	2026-12-07		Pediatric extension	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7550153	2024-09-30	U-859		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7553498	2024-09-30	U-859		`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7838027	2024-09-30	U-859	Drug product	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7550153*PED	2025-03-30		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7553498*PED	2025-03-30		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7838027*PED	2025-03-30		Pediatric extension	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022020-001	7544370	2026-06-07		Drug product	`2680178bc6a6…`

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

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 [CARDINAL HEALTH]	8
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
HYPROMELLOSE 2910 (5 MPA.S)	INACTIVE INGREDIENT	R75537T0T4	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
HYPROMELLOSE 2910 (6 MPA.S)	INACTIVE INGREDIENT	0WZ8WG20P6	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
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 [CARDINAL HEALTH]	8
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH]	8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-4232	PROTONIX DELAYED-RELEASE (PANTOPRAZOLE SODIUM) GRANULE, DELAYED RELEASE [CARDINAL HEALTH 107, LLC]	14	Legacy NDC	20241013_189b7b6a-9717-44eb-b87b-fd3e985b2268.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): 022020 application number: NDA022020

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
55154-4232-0	55154423200	10 PACKET in 1 BAG (55154-4232-0) > 40 GRANULE, DELAYED RELEASE in 1 PACKET	10 packet	2008-02-29	0000-00-00	No	No	Current