Pantoprazole Sodium

Product NDC: 50268-639
11-digit product format: 502680639
Labeler code: 50268
Product ID: 50268-639_47fb0652-007e-e12b-e063-6294a90ab81a
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: AvPAK
Application: ANDA078281
Marketing category: ANDA
Marketing start: 2015-02-19
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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A078281-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-20
A078281-002	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-20

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A078281-001	AB
A078281-002	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 · 86 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
2026-09-14 22:38:34	2026-08	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078281-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078281-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-20	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A078281-001	AB	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A078281-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A078281-001	AB	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A078281-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A078281-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A078281-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A078281-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A078281-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A078281-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A078281-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A078281-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A078281-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A078281-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A078281-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A078281-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A078281-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A078281-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A078281-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A078281-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A078281-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A078281-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A078281-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A078281-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A078281-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A078281-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A078281-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A078281-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A078281-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A078281-002	AB	1	`74a2ff9319b5…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Pantoprazole Sodium
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
6871619Q5X	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
251872	Internal RxNorm lookup
314200	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
dcac4022-fea1-67c5-3331-fefcc3c440d8	Available on FDA.report

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
50268-639-11	Pantoprazole Sodium	1 in 1 BLISTER PACK	TABLET, DELAYED RELEASE	1		13
50268-639-15	Pantoprazole Sodium	50 in 1 BOX	TABLET, DELAYED RELEASE	50		13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50268-639-11	EA - Each	50268-639	6c10eb8a-cf79-4dfb-bda3-5e61356e48cd	1	2015-11-12
50268-639-15	EA - Each	50268-639	b539062b-3f79-4c16-8781-7c8288251386	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 (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
crospovidone	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
FERROSOFERRIC OXIDE	INACTIVE INGREDIENT	XM0M87F357	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
glyceryl dibehenate	INACTIVE INGREDIENT	R8WTH25YS2	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
hypromelloses	INACTIVE INGREDIENT	3NXW29V3WO	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
isopropyl alcohol	INACTIVE INGREDIENT	ND2M416302	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
lactose monohydrate	INACTIVE INGREDIENT	EWQ57Q8I5X	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
METHACRYLIC ACID - METHYL METHACRYLATE COPOLYMER (1:1)	INACTIVE INGREDIENT	74G4R6TH13	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
talc	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
titanium dioxide	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5
triethyl citrate	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM) TABLET, DELAYED RELEASE [AVPAK]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50268-639	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [AVPAK]	12	Current NDC, Legacy NDC, 2 package rows	20220913_dcac4022-fea1-67c5-3331-fefcc3c440d8.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 · 10 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	dcac4022-fea1-67c5-3331-fefcc3c440d8	2026-01-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281 ndc (product): 50268-639
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	410d5577-e50a-44f3-aaa8-fbf391a0c261	2025-12-30	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Chartwell RX, LLC	42a969c3-1144-4151-9cf3-3e9bace6a380	2025-12-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	AvPAK	b9fa8381-b75e-b1cd-e053-2a95a90a9883	2025-12-03	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	PD-Rx Pharmaceuticals, Inc.	b422c5eb-9a6d-4f8c-863d-ca515ec780c2	2025-10-02	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Aphena Pharma Solutions - Tennessee, LLC	c9bc288b-e84c-4e31-a769-c87a59226086	2025-06-09	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Bryant Ranch Prepack	3e5421ef-0875-4a04-b17d-95cca0052c83	2024-04-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Golden State Medical Supply, Inc.	d6aae78e-308b-7072-e053-2a95a90aaa10	2024-03-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Lannett Company, Inc.	e7705bf6-e473-4b9c-bb5d-57e26ffe7b97	2023-07-21	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Proficient Rx LP	a03aa46f-9eb5-4cf4-addf-745d94af8261	2022-06-01	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 078281 application number: ANDA078281

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	dcac4022-fea1-67c5-3331-fefcc3c440d8	13
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	dcac4022-fea1-67c5-3331-fefcc3c440d8	13
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	dcac4022-fea1-67c5-3331-fefcc3c440d8	13
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	dcac4022-fea1-67c5-3331-fefcc3c440d8	13
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	dcac4022-fea1-67c5-3331-fefcc3c440d8	13
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	dcac4022-fea1-67c5-3331-fefcc3c440d8	13

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
50268-639-11	50268063911	1 in 1 BLISTER PACK						Historical
50268-639-15	50268063915	50 BLISTER PACK in 1 BOX (50268-639-15) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (50268-639-11)	50 blister pack	2015-02-19	0000-00-00	No	No	Current