Protonix

Product NDC: 0008-0941
11-digit product format: 000080941
Labeler code: 0008
Product ID: 0008-0941_4770025a-60c9-492e-9d19-51ec395efef9
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pantoprazole sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application: NDA020988
Marketing category: NDA
Marketing start: 2001-05-01
Marketing end: 0000-00-00
Substance: PANTOPRAZOLE SODIUM
Active strength: 40 mg/10mL
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2021-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	0008-0941		D	Discontinued by firm	2026-08-11
excluded package	package	0008-0941	0008-0941-02	D	Discontinued by firm	2026-08-11
excluded package	package	0008-0941	0008-0941-03	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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0008-0941-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	0008-0941-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0008-0941-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	0008-0941-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0008-0941-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	0008-0941-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0008-0941-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	0008-0941-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0008-0941-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	0008-0941-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0008-0941-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	0008-0941-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0008-0941-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	0008-0941-03	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0008-0941-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	0008-0941-03	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0008-0941-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	0008-0941-03	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0008-0941-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	0008-0941-03	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0008-0941-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	0008-0941-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0008-0941-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	0008-0941-03	`557ba5c1ecfa…`	`9c80585c8c6e…`

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
N020988-001	PROTONIX IV	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N020988-001	AP

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N020988-001	NPP	2027-08-12

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	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / IV (INFUSION)	AP	RLD, RS	2001-03-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020988-001	PROTONIX IV	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	RLD, RS	2001-03-22	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 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	N020988-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020988-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020988-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020988-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020988-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020988-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020988-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020988-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020988-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020988-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020988-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020988-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020988-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020988-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020988-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020988-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020988-001	AP	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020988-001	AP	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020988-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020988-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020988-001	AP	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020988-001	AP	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020988-001	AP	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020988-001	AP	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020988-001	AP	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020988-001	AP	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020988-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020988-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020988-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020988-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020988-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020988-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020988-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020988-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020988-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020988-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020988-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020988-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020988-001	AP	1	`cb3db0bc1861…`

Observed Orange Book patent history#

Patent history page 1 of 3 · 81 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020988-001	6780881	2021-11-17	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020988-001	7351723	2021-11-17	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020988-001	8754108	2021-11-17	Drug product	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020988-001	6780881	2021-11-17	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020988-001	7351723	2021-11-17	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020988-001	8754108	2021-11-17	Drug product	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	6780881	2021-11-17	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	7351723	2021-11-17	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	8754108	2021-11-17	Drug product	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`87673890dc5c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020988-001	6780881	2021-11-17	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020988-001	7351723	2021-11-17	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020988-001	8754108	2021-11-17	Drug product	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020988-001	7351723*PED	2022-05-17	Pediatric extension	`5aa47cf7b7d7…`
2021-03-12 10:30 UTC	2021-03	N020988-001	8754108*PED	2022-05-17	Pediatric extension	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020988-001	6780881	2021-11-17	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020988-001	7351723	2021-11-17	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020988-001	8754108	2021-11-17	Drug product	`8869cabd3fbd…`
2020-12-22 03:56 UTC	2020-12	N020988-001	6780881*PED	2022-05-17	Pediatric extension	`8869cabd3fbd…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020988-001	NPP	2027-08-12	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020988-001	NPP	2027-08-12	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020988-001	NPP	2027-08-12	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020988-001	NPP	2027-08-12	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020988-001	NPP	2027-08-12	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020988-001	NPP	2027-08-12	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020988-001	NPP	2027-08-12	`2680178bc6a6…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020988-001	NPP	2027-08-12	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020988-001	NPP	2027-08-12	`d06236e962d9…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020988-001	NPP	2027-08-12	`a50c72e98297…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0008-0941-01	EA - Each	0008-0941	8be98f26-79f5-46da-b669-52c3e86e927b	1	2012-07-24
0008-0941-02	EA - Each	0008-0941	0426f7cf-c54d-4818-bd67-d7d53fab9929	1	2012-07-24
0008-0941-03	EA - Each	0008-0941	a8fbe440-98f9-4710-b9a4-de13b5125328	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	31
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	31
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	31
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PROTONIX I.V. (PANTOPRAZOLE SODIUM) INJECTION, POWDER, FOR SOLUTION [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.]	31

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Protonix I.V.	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	51e4144a-489e-436c-609a-39305f8f56ba	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020988 application number: NDA020988
Protonix I.V.	PANTOPRAZOLE SODIUM	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	f39b3e7d-39d2-4c8a-9974-4ab885241880	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020988 application number: NDA020988
Protonix I.V.	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	50802e19-72d3-4130-8d14-eb94361b38e7	2025-08-19	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020988 application number: NDA020988
Protonix I.V.	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	3cde88e6-28f2-4cbe-8c3f-770b05cc0e1b	2025-04-22	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020988 application number: NDA020988

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6871619Q5X	PANTOPRAZOLE SODIUM	164579-32-2	PANTOPRAZOLE SODIUM

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
pantoprazole sodium	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. \| Takeda GmbH \| Pharmacia and Upjohn Company LLC	2020-09-18	HUMAN PRESCRIPTION DRUG LABEL	40