Protonix

Product NDC: 21695-108
11-digit product format: 216950108
Labeler code: 21695
Product ID: 21695-108_cfeacb5c-8b1b-48f6-9acf-00044a8179b4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pantoprazoel sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Rebel Distributors Corp
Application: NDA020987
Marketing category: NDA
Marketing start: 2001-08-28
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: E
Listing certified through: 2017-12-31
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	21695-108		I	Inactivated by FDA		2026-08-03
excluded package	package	21695-108	21695-108-15	I	Inactivated by FDA		2026-08-03

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 · 44 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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`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	21695-108-15	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	21695-108-15	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	21695-108-15	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	21695-108-15	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	21695-108-15	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	21695-108-15	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	21695-108-15	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	21695-108-15	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	21695-108-15	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	21695-108-15	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	21695-108-15	`110d247fa046…`	`a55b01930146…`

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…`

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
21695-108-15	2019-09-24	C162847	48780-1	934fe258-47a9-48b1-e053-8cdaa90a720a	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 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
21695-108-15	Protonix	15 in 1 BOTTLE	TABLET, DELAYED RELEASE	15		1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
21695-108-15	EA - Each	21695-108	9712077f-8c7f-4c4e-8b39-73de727bceac	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
21695-108	PROTONIX (PANTOPRAZOEL SODIUM) TABLET, DELAYED RELEASE [REBEL DISTRIBUTORS CORP]	1	Legacy NDC, 1 package rows	20110622_cfeacb5c-8b1b-48f6-9acf-00044a8179b4.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

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	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
284400	Protonix 40 MG Delayed Release Oral Tablet	PSN	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
284400	pantoprazole 40 MG Delayed Release Oral Tablet [Protonix]	SBD	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
284400	Protonix 40 MG (pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1
284400	Protonix 40 MG Delayed Release Oral Tablet	SY	cfeacb5c-8b1b-48f6-9acf-00044a8179b4	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
21695-108-15	21695010815	15 in 1 BOTTLE	Historical