Pantoprazole Sodium

Product NDC: 43353-569
11-digit product format: 433530569
Labeler code: 43353
Product ID: 43353-569_3b96d2e8-c6df-487e-a159-b094dba435cf
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Aphena Pharma Solutions - Tennessee, LLC
Application: ANDA205119
Marketing category: ANDA
Marketing start: 2016-06-20
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 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	43353-569		I	Inactivated by FDA	2026-08-17
excluded package	package	43353-569	43353-569-30	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-569	43353-569-53	I	Inactivated by FDA	2026-08-17
excluded package	package	43353-569	43353-569-80	I	Inactivated by FDA	2026-08-17

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 2 · 84 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	43353-569-80	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-569-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	43353-569-53	`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	43353-569-80	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-569-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	43353-569-53	`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	43353-569-80	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-569-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	43353-569-53	`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	43353-569-80	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-569-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	43353-569-53	`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	43353-569-80	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-569-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	43353-569-53	`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	43353-569-80	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-569-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	43353-569-53	`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	43353-569-80	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-569-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	43353-569-53	`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	43353-569-80	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-569-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	43353-569-53	`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	43353-569-80	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-569-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	43353-569-53	`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	43353-569-80	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-569-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	43353-569-53	`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	43353-569-80	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-569-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	43353-569-53	`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	43353-569-80	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-569-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	43353-569-53	`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	43353-569-80	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-569-30	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	43353-569-53	`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	43353-569-80	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-569-30	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	43353-569-53	`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	43353-569-80	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-569-30	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	43353-569-53	`1332a3947898…`	`d4bfe170f9cd…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A205119-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2016-01-26
A205119-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2016-01-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A205119-001	AB
A205119-002	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 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205119-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205119-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2016-01-26	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A205119-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A205119-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A205119-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A205119-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A205119-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A205119-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A205119-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A205119-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A205119-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A205119-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A205119-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A205119-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A205119-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A205119-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A205119-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A205119-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A205119-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A205119-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A205119-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A205119-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A205119-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A205119-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A205119-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A205119-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A205119-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A205119-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A205119-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A205119-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A205119-002	AB	1	`bb7c543d1eb4…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041	Product name	8	20260304
41d62193-73fc-49cf-9907-add9588e2da1	Product name	9	20260112
f12d0d0d-c068-46c6-872c-96c9d38533bb	Product name	1	20250116
594e2c86-3079-4e6e-96c9-48f7a8afc78d	Product name	1	20230718
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4	Product name	1	20230718
a62a50ac-1535-4461-9768-8ae703e2e9fb	Product name	1	20210525
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508
bc07ef78-e82d-0c19-31f4-31f263780582	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43353-569-30	2020-01-31	C162847	48780-1	9d75b9d1-1050-f424-e053-dadaa90a57ce	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 USP, for oral use Initial U.S. Approval: 2000
43353-569-53	2020-01-31	C162847	48780-1	9d75b9d1-1050-f424-e053-dadaa90a57ce	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 USP, for oral use Initial U.S. Approval: 2000
43353-569-80	2020-01-31	C162847	48780-1	9d75b9d1-1050-f424-e053-dadaa90a57ce	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 USP, for oral use Initial U.S. Approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
43353-569-30	Pantoprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	1
43353-569-53	Pantoprazole Sodium	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60	1
43353-569-80	Pantoprazole Sodium	180 in 1 BOTTLE	TABLET, DELAYED RELEASE	180	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43353-569-30	EA - Each	43353-569	7c3e0778-e133-4668-91f4-f229be6e7dff	1	2017-12-14
43353-569-53	EA - Each	43353-569	c26c88a1-ae22-4bd4-9134-cf5c3eba0143	1	2017-12-14
43353-569-80	EA - Each	43353-569	93bf8d49-dd88-4c20-a8d2-a88464d02c69	1	2017-10-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43353-569	PANTOPRAZOLE SODIUM (PANTOPRAZOLE) TABLET, DELAYED RELEASE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]	1	Legacy NDC, 3 package rows	20171003_07d68e39-155f-4816-989c-4df00b5cca4b.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 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE	Amneal Pharmaceuticals LLC	f3ded82a-cf0d-4844-944a-75f9f9215ff0	2026-03-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium	PANTOPRAZOLE	PHOENIX RX LLC	440b9ae8-2fb8-5d35-e063-6294a90a82b6	2025-11-20	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium	PANTOPRAZOLE	Bryant Ranch Prepack	d212e8ec-f7ff-4727-a83e-0edc4ca7e6d1	2025-09-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium DR	PANTOPRAZOLE SODIUM	Advanced Rx of Tennessee, LLC	b3277cb8-26d0-bce0-e053-2a95a90af6dd	2024-12-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium	PANTOPRAZOLE	Proficient Rx LP	a7dc4321-331d-49af-976c-cfd69d0055d9	2022-05-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119
Pantoprazole Sodium	PANTOPRAZOLE	Proficient Rx LP	6d03491f-20c6-4878-9741-2e21e221eff2	2019-11-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 205119 application number: ANDA205119

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
6871619Q5X	PANTOPRAZOLE SODIUM	164579-32-2	PANTOPRAZOLE SODIUM
D8TST4O562	PANTOPRAZOLE	102625-70-7	Pantoprazole

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	07d68e39-155f-4816-989c-4df00b5cca4b	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	07d68e39-155f-4816-989c-4df00b5cca4b	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	07d68e39-155f-4816-989c-4df00b5cca4b	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
43353-569-30	43353056930	30 in 1 BOTTLE	Historical
43353-569-53	43353056953	60 in 1 BOTTLE	Historical
43353-569-80	43353056980	180 in 1 BOTTLE	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium	Aphena Pharma Solutions - Tennessee, LLC	2017-08-01	HUMAN PRESCRIPTION DRUG LABEL	1