PANTOPRAZOLE SODIUM

Product NDC: 50436-8102
11-digit product format: 504368102
Labeler code: 50436
Product ID: 50436-8102_4e19dea0-3cdd-4454-bca1-471c47ddb09c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Unit Dose Services
Application: ANDA091231
Marketing category: ANDA
Marketing start: 2011-01-19
Marketing end: 0000-00-00
Substance: PANTOPRAZOLE SODIUM
Active strength: 20 mg/1
Pharmacologic classes: Proton Pump Inhibitor [EPC],Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2020-12-31
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	50436-8102		I	Inactivated by FDA		2026-08-03
excluded package	package	50436-8102	50436-8102-2	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 · 38 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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`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	50436-8102-2	`8dfbde2a14a4…`	`c9ff85d89658…`

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
A091231-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-19
A091231-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-19

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A091231-001	AB
A091231-002	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	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091231-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091231-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`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	A091231-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A091231-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091231-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A091231-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A091231-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A091231-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091231-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A091231-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091231-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A091231-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091231-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A091231-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091231-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A091231-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091231-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A091231-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091231-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A091231-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A091231-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A091231-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091231-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A091231-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091231-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A091231-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091231-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A091231-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A091231-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A091231-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091231-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A091231-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A091231-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A091231-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A091231-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A091231-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A091231-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A091231-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A091231-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A091231-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A091231-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A091231-002	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
50436-8102-2	2021-01-29	C162847	48780-1	ba0f9c33-1a2d-a910-e053-dadaa90a0b85	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, for oral use Initial U.S. approval: 2000

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50436-8102-2	PANTOPRAZOLE SODIUM	60 in 1 BOTTLE	TABLET, DELAYED RELEASE	60		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50436-8102-2	EA - Each	50436-8102	0b061b74-6c81-4f55-ac99-8e2764a32b1f	1	2015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
FD&C BLUE NO. 2	INACTIVE INGREDIENT	L06K8R7DQK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
HYPROMELLOSES	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
POLYETHYLENE GLYCOL 4000	INACTIVE INGREDIENT	4R4HFI6D95	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
POLYETHYLENE GLYCOL 6000	INACTIVE INGREDIENT	30IQX730WE	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
SODIUM STARCH GLYCOLATE TYPE A POTATO	INACTIVE INGREDIENT	5856J3G2A2	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
STARCH, CORN	INACTIVE INGREDIENT	O8232NY3SJ	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50436-8102	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [UNIT DOSE SERVICES]	4	Legacy NDC, 1 package rows	20190106_e483f0bc-9aff-46a9-baa2-d4e558c62b57.zip

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
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	e483f0bc-9aff-46a9-baa2-d4e558c62b57	4
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	e483f0bc-9aff-46a9-baa2-d4e558c62b57	4
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	e483f0bc-9aff-46a9-baa2-d4e558c62b57	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
50436-8102-2	50436810202	60 in 1 BOTTLE	Historical