Pantoprazole Sodium

Product NDC: 43353-338
11-digit product format: 433530338
Labeler code: 43353
Product ID: 43353-338_d210a49a-4415-4bb1-b333-8027e459711b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: pantoprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: NDA020987
Marketing category: NDA
Marketing start: 2008-01-31
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: 2019-12-31
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 · 7 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-338		I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-09	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-30	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-53	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-60	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-79	I	Inactivated by FDA	2026-08-03
excluded package	package	43353-338	43353-338-88	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 3 · 147 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	43353-338-88	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-338-60	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-338-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-338-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-338-79	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-338-53	`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	43353-338-88	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-338-60	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-338-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-338-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-338-79	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-338-53	`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	43353-338-88	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-338-60	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-338-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-338-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-338-79	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-338-53	`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	43353-338-88	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-338-60	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-338-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-338-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-338-79	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-338-53	`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	43353-338-88	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-338-60	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-338-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-338-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-338-79	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-338-53	`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	43353-338-88	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-338-60	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-338-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-338-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-338-79	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-338-53	`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	43353-338-88	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-338-60	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-338-09	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-338-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-338-79	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-338-53	`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	43353-338-88	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-338-60	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-338-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-338-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-338-79	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-338-53	`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	43353-338-88	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-338-60	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-338-09	`0efc9e666f02…`	`f202fb6c5f17…`

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
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, Related label table
NDC	Related label
43353-338-09	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000
43353-338-30	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000
43353-338-53	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000
43353-338-60	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000
43353-338-79	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000
43353-338-88	These highlights do not include all the information needed to use Pantoprazole Sodium Delayed-Release Tablets safely and effectively. See full prescribing information for Pantoprazole Sodium Delayed-Release Tablets. PANTOPRAZOLE SODIUM delayed-release tablets Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-338-09	Pantoprazole Sodium Delayed-Release	9000 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	9000	3
43353-338-30	Pantoprazole Sodium Delayed-Release	30 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	30	3
43353-338-53	Pantoprazole Sodium Delayed-Release	60 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	60	3
43353-338-60	Pantoprazole Sodium Delayed-Release	90 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	90	3
43353-338-79	Pantoprazole Sodium Delayed-Release	2160 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	2160	3
43353-338-88	Pantoprazole Sodium Delayed-Release	900 in 1 BOTTLE, PLASTIC	TABLET, DELAYED RELEASE	900	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-338-09	EA - Each	43353-338	548115d6-ea1e-42fa-b485-0ab00223359b	1	2014-01-04
43353-338-30	EA - Each	43353-338	b7148084-0694-4016-9c09-f63415e1b735	1	2013-02-13
43353-338-53	EA - Each	43353-338	7d1cb604-32fd-4758-97e9-399042fa9155	1	2013-03-03
43353-338-60	EA - Each	43353-338	b2e68dff-f7a8-49d7-accf-e7f8dd7adb98	1	2014-01-04
43353-338-79	EA - Each	43353-338	767bdaea-93d5-4842-99de-befdfe020c92	1	2014-10-03
43353-338-88	EA - Each	43353-338	e7873c26-3c30-4fc2-8161-00d2f0e5063c	1	2013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
HYPROMELLOSE 2208 (100 MPA.S)	INACTIVE INGREDIENT	B1QE5P712K	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POVIDONE K25	INACTIVE INGREDIENT	K0KQV10C35	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
POVIDONE K90	INACTIVE INGREDIENT	RDH86HJV5Z	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-338	PANTOPRAZOLE SODIUM DELAYED-RELEASE (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	3	Legacy NDC, 6 package rows	20140422_03974abc-ad03-44da-b7b6-d8e6c4a06105.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	03974abc-ad03-44da-b7b6-d8e6c4a06105	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	03974abc-ad03-44da-b7b6-d8e6c4a06105	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	03974abc-ad03-44da-b7b6-d8e6c4a06105	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-338-09	43353033809	9000 in 1 BOTTLE, PLASTIC	Historical
43353-338-30	43353033830	30 in 1 BOTTLE, PLASTIC	Historical
43353-338-53	43353033853	60 in 1 BOTTLE, PLASTIC	Historical
43353-338-60	43353033860	90 in 1 BOTTLE, PLASTIC	Historical
43353-338-79	43353033879	2160 in 1 BOTTLE, PLASTIC	Historical
43353-338-88	43353033888	900 in 1 BOTTLE, PLASTIC	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium Delayed-Release	Aphena Pharma Solutions - Tennessee, LLC	2014-04-15	HUMAN PRESCRIPTION DRUG LABEL	3