Pantoprazole Sodium

Product NDC: 43063-618
Requested package NDC: 43063-618-30
11-digit product format: 430630618
Labeler code: 43063
Product ID: 43063-618_cb6ec7ec-5ebd-f120-e053-2995a90a346c
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: PD-Rx Pharmaceuticals, Inc.
Application: ANDA202038
Marketing category: ANDA
Marketing start: 2015-05-01
Marketing end: 2022-10-31
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: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	43063-618	43063-618-30	D	Discontinued by firm		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 · 12 matching rows.

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

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

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
A202038-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-09-28
A202038-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2012-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A202038-001	AB
A202038-002	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	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202038-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202038-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2012-09-28	`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	A202038-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A202038-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A202038-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A202038-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A202038-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A202038-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A202038-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A202038-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A202038-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A202038-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A202038-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A202038-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A202038-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A202038-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A202038-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A202038-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A202038-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A202038-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A202038-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A202038-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A202038-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A202038-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A202038-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A202038-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A202038-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A202038-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A202038-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A202038-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A202038-002	AB	1	`782e0a99824c…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
43063-618-30	EA - Each	43063-618	49d5b32f-ef44-4caa-9c58-bfc3001d9823	1	2015-11-12

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
AMMONIA	INACTIVE INGREDIENT	5138Q19F1X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
BUTYL ALCOHOL	INACTIVE INGREDIENT	8PJ61P6TS3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
HYDROXYPROPYL CELLULOSE (TYPE L)	INACTIVE INGREDIENT	UKE75GEA7F	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
ISOPROPYL ALCOHOL	INACTIVE INGREDIENT	ND2M416302	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
SHELLAC	INACTIVE INGREDIENT	46N107B71O	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [PD-RX PHARMACEUTICALS, INC.]	7

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 2 · 29 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	76e1839b-7462-4344-b319-001a5f57d67a	2026-07-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f38a6df2-1dd4-48bf-9ec4-1113ce492e78	2026-07-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	558dc7e1-dfd5-d3d7-e063-6394a90ab9c3	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	REMEDYREPACK INC.	f313159c-115a-4cf6-b32e-9ddc833fd51c	2026-07-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Unit Dose Solutions, Inc.	5566b4b1-b4f5-4020-e063-6394a90a5257	2026-06-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	HAWAII REPACK, INC.	f403c94d-68b7-43df-8c8e-c9fef3309cfc	2026-06-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	03dea010-4bae-43ab-893e-9bbddb58062d	2026-06-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	5331f534-4724-52e8-e063-6394a90aa548	2026-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Coupler LLC	52bbab54-9f11-77bc-e063-6394a90ab449	2026-05-26	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	9a1159d3-b9fa-4026-962c-d3001002e610	2026-05-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	QPharma Inc	0e200326-8885-18d0-e063-6294a90aad2f	2026-05-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aurobindo Pharma Limited	7418f358-f536-4de6-adf0-562b4373f2e3	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NorthStar Rx LLC	6637d90b-b268-4a5f-ab5b-885f2d5f0d4b	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Burel Pharmaceuticals, LLC	3cc5197e-6b39-4415-b963-d4bbeecd7953	2026-02-06	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	6229247e-ee15-466e-a8ac-adcd646b738d	2026-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Major Pharmaceuticals	de419aa0-caa9-40fb-bc6d-e341c94273c7	2026-01-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	f2a1af50-a051-3e55-e053-2a95a90a9184	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northwind Health Company, LLC	d9deb251-96d3-5f96-e053-2a95a90a0792	2026-01-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals,Inc.	8aac1642-6cb0-6ad2-e053-2a95a90a4cbd	2025-01-31	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Quality Care Products, LLC	a9fbf3b5-ddf4-4d3a-8b69-a0c38b3fa5e2	2024-12-19	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 202038 application number: ANDA202038

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
43063-618-30	43063061830	30 TABLET, DELAYED RELEASE in 1 BOTTLE, PLASTIC (43063-618-30)	2015-05-02	2022-10-31	No	No	Current