Pantoprazole Sodium

Product NDC: 13668-429
11-digit product format: 136680429
Labeler code: 13668
Product ID: 13668-429_7d09300f-2078-458c-9328-f83ffd997c9e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: TABLET, DELAYED RELEASE
Route: ORAL
Labeler: Torrent Pharmaceuticals Limited
Application: ANDA090074
Marketing category: ANDA
Marketing start: 2011-01-20
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 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
A090074-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB		2011-01-19
A090074-002	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
A090074-001	AB
A090074-002	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	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090074-002	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	A090074-001	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	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	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	A090074-001	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	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090074-002	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	A090074-001	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	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090074-002	PANTOPRAZOLE SODIUM	EQ 40MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090074-001	PANTOPRAZOLE SODIUM	EQ 20MG BASE	TABLET, DELAYED RELEASE / ORAL	AB	2011-01-19	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090074-002	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	A090074-001	AB	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A090074-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090074-001	AB	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090074-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090074-001	AB	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A090074-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090074-001	AB	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090074-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090074-001	AB	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090074-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090074-001	AB	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090074-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090074-001	AB	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090074-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090074-001	AB	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090074-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090074-001	AB	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090074-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090074-001	AB	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A090074-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090074-001	AB	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090074-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090074-001	AB	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090074-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090074-001	AB	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090074-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090074-001	AB	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A090074-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090074-001	AB	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090074-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090074-001	AB	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A090074-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090074-001	AB	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A090074-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090074-001	AB	1	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	A090074-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090074-001	AB	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A090074-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090074-001	AB	1	`782e0a99824c…`
2021-12-28 21:50 UTC	2021-12	A090074-002	AB	1	`782e0a99824c…`

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
9c983da1-a8e0-479e-8816-5d5668ea242e	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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
13668-429-05	Pantoprazole Sodium	500 in 1 BOTTLE	TABLET, DELAYED RELEASE	500	27
13668-429-10	Pantoprazole Sodium	1000 in 1 BOTTLE	TABLET, DELAYED RELEASE	1000	27
13668-429-30	Pantoprazole Sodium	30 in 1 BOTTLE	TABLET, DELAYED RELEASE	30	27
13668-429-90	Pantoprazole Sodium	90 in 1 BOTTLE	TABLET, DELAYED RELEASE	90	27

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
13668-429-05	EA - Each	13668-429	289bcdb8-c6c2-4b15-976d-20c25edb1961	1	2012-07-24
13668-429-30	EA - Each	13668-429	a86ec8f9-4139-4237-89ba-5f209e63fedf	1	2012-07-24
13668-429-90	EA - Each	13668-429	b3be4dfc-e71e-480b-ac59-1df04c56ed43	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
HYDROXYPROPYL CELLULOSE	INACTIVE INGREDIENT	RFW2ET671P	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
SODIUM CARBONATE DECAHYDRATE	INACTIVE INGREDIENT	LS505BG22I	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	10
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYDROXYPROPYL CELLULOSE (TYPE H)	INACTIVE INGREDIENT	RFW2ET671P	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM CARBONATE	INACTIVE INGREDIENT	45P3261C7T	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
SODIUM CARBONATE DECAHYDRATE	INACTIVE INGREDIENT	LS505BG22I	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [STATE OF FLORIDA DOH CENTRAL PHARMACY]	2
PANTOPRAZOLE SODIUM	ACTIVE INGREDIENT	6871619Q5X	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
PANTOPRAZOLE	ACTIVE MOIETY	D8TST4O562	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
CALCIUM STEARATE	INACTIVE INGREDIENT	776XM7047L	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
CROSPOVIDONE	INACTIVE INGREDIENT	68401960MK	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
HYDROXYPROPYL CELLULOSE (TYPE E)	INACTIVE INGREDIENT	66O7AQV0RT	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
HYPROMELLOSE 2910 (3 MPA.S)	INACTIVE INGREDIENT	0VUT3PMY82	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
MANNITOL	INACTIVE INGREDIENT	3OWL53L36A	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A	INACTIVE INGREDIENT	NX76LV5T8J	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
SODIUM CARBONATE DECAHYDRATE	INACTIVE INGREDIENT	LS505BG22I	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1
TRIETHYL CITRATE	INACTIVE INGREDIENT	8Z96QXD6UM	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [MAJOR PHARMACEUTICALS]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
13668-429	PANTOPRAZOLE SODIUM TABLET, DELAYED RELEASE [TORRENT PHARMACEUTICALS LIMITED]	25	Current NDC, Legacy NDC, 4 package rows	20240706_9c983da1-a8e0-479e-8816-5d5668ea242e.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 · 5 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Cardinal Health 107, LLC	6b5ed424-2203-482f-bb85-2c97d9c356f2	2026-02-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090074 application number: ANDA090074
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Major Pharmaceuticals	9c286e5c-2b36-422b-9f74-e8c0abb3f747	2026-02-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090074 application number: ANDA090074
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Torrent Pharmaceuticals Limited	9c983da1-a8e0-479e-8816-5d5668ea242e	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090074 application number: ANDA090074 ndc (product): 13668-429
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	A-S Medication Solutions	81696241-17d5-4d35-9e59-8c28469ffd2c	2025-03-14	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090074 application number: ANDA090074
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	NuCare Pharmaceuticals, Inc.	4fbec80c-b38d-122c-e054-00144ff88e88	2024-07-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090074 application number: ANDA090074

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	9c983da1-a8e0-479e-8816-5d5668ea242e	27
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	9c983da1-a8e0-479e-8816-5d5668ea242e	27
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	9c983da1-a8e0-479e-8816-5d5668ea242e	27
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	9c983da1-a8e0-479e-8816-5d5668ea242e	27
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	9c983da1-a8e0-479e-8816-5d5668ea242e	27
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	9c983da1-a8e0-479e-8816-5d5668ea242e	27
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	9c286e5c-2b36-422b-9f74-e8c0abb3f747	9
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	9c286e5c-2b36-422b-9f74-e8c0abb3f747	9
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	9c286e5c-2b36-422b-9f74-e8c0abb3f747	9
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	4fbec80c-b38d-122c-e054-00144ff88e88	4
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	4fbec80c-b38d-122c-e054-00144ff88e88	4
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	4fbec80c-b38d-122c-e054-00144ff88e88	4
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	8fbb2e3d-6354-401d-a403-b2541081e096	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	73a3cb78-d847-2dda-e053-2a91aa0a284f	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	8fbb2e3d-6354-401d-a403-b2541081e096	3
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	81696241-17d5-4d35-9e59-8c28469ffd2c	3
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	8fbb2e3d-6354-401d-a403-b2541081e096	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	73a3cb78-d847-2dda-e053-2a91aa0a284f	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	8fbb2e3d-6354-401d-a403-b2541081e096	3
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	81696241-17d5-4d35-9e59-8c28469ffd2c	3
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	8fbb2e3d-6354-401d-a403-b2541081e096	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	81696241-17d5-4d35-9e59-8c28469ffd2c	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	73a3cb78-d847-2dda-e053-2a91aa0a284f	3
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	8fbb2e3d-6354-401d-a403-b2541081e096	3
251872	pantoprazole sodium 20 MG Delayed Release Oral Tablet	PSN	801780eb-30c9-4161-b7b0-e433fd04bc43	2
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	801780eb-30c9-4161-b7b0-e433fd04bc43	2
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	914372d5-3500-4e91-e053-2a95a90a4855	2
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	913221df-021c-e511-e053-2995a90a4948	2
251872	pantoprazole 20 MG Delayed Release Oral Tablet	SCD	801780eb-30c9-4161-b7b0-e433fd04bc43	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	913221df-021c-e511-e053-2995a90a4948	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	914372d5-3500-4e91-e053-2a95a90a4855	2
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	801780eb-30c9-4161-b7b0-e433fd04bc43	2
251872	pantoprazole 20 MG (as pantoprazole sodium sesquihydrate 22.56 MG) Delayed Release Oral Tablet	SY	801780eb-30c9-4161-b7b0-e433fd04bc43	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	914372d5-3500-4e91-e053-2a95a90a4855	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	913221df-021c-e511-e053-2995a90a4948	2
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	801780eb-30c9-4161-b7b0-e433fd04bc43	2
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	ac397028-d91b-5089-e053-2a95a90ac0c9	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	7cc5510a-8777-3878-e053-2a91aa0a5d32	1
314200	pantoprazole sodium 40 MG Delayed Release Oral Tablet	PSN	095d5a6a-c0da-4026-9779-3be051641f40	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	7cc5510a-8777-3878-e053-2a91aa0a5d32	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	095d5a6a-c0da-4026-9779-3be051641f40	1
314200	pantoprazole 40 MG Delayed Release Oral Tablet	SCD	ac397028-d91b-5089-e053-2a95a90ac0c9	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	7cc5510a-8777-3878-e053-2a91aa0a5d32	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	ac397028-d91b-5089-e053-2a95a90ac0c9	1
314200	pantoprazole 40 MG (as pantoprazole sodium sesquihydrate 45.1 MG) Delayed Release Oral Tablet	SY	095d5a6a-c0da-4026-9779-3be051641f40	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
13668-429-05	13668042905	500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-05)	2011-01-20	0000-00-00	No	No	Current
13668-429-10	13668042910	1000 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-10)	2025-11-03		No	No	Current
13668-429-30	13668042930	30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-30)	2011-01-20	0000-00-00	No	No	Current
13668-429-77	13668042977	80 TABLET, DELAYED RELEASE in 1 CARTON (13668-429-77)	2011-01-20	0000-00-00	No	No	Current
13668-429-90	13668042990	90 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-429-90)	2011-01-20	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium	Major Pharmaceuticals	2026-02-12	HUMAN PRESCRIPTION DRUG LABEL	9
Pantoprazole Sodium	Torrent Pharmaceuticals Limited \| Torrent Pharma, Inc.	2026-02-05	HUMAN PRESCRIPTION DRUG LABEL	27
Pantoprazole Sodium	A-S Medication Solutions	2025-03-14	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	A-S Medication Solutions	2025-02-28	HUMAN PRESCRIPTION DRUG LABEL	8
Pantoprazole Sodium	Preferred Pharmaceuticals Inc.	2024-07-29	HUMAN PRESCRIPTION DRUG LABEL	8
Pantoprazole Sodium	NuCare Pharmaceuticals, Inc.	2024-07-15	HUMAN PRESCRIPTION DRUG LABEL	4
PANTOPRAZOLE SODIUM D/R	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
PANTOPRAZOLE SODIUM D/R	Direct_Rx	2022-10-05	HUMAN PRESCRIPTION DRUG LABEL	2
Pantoprazole Sodium	REMEDYREPACK INC.	2022-06-06	HUMAN PRESCRIPTION DRUG LABEL	12
Pantoprazole Sodium	Bryant Ranch Prepack	2022-05-02	HUMAN PRESCRIPTION DRUG LABEL	15
Pantoprazole Sodium	Bryant Ranch Prepack	2022-04-29	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	REMEDYREPACK INC.	2022-01-07	HUMAN PRESCRIPTION DRUG LABEL	11
Pantoprazole Sodium	NuCare Pharmaceuticals,Inc.	2021-02-11	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	Denton Pharma, Inc. DBA Northwind Pharmaceuticals	2021-01-22	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	NuCare Pharmaceuticals,Inc.	2020-08-06	HUMAN PRESCRIPTION DRUG LABEL	1
Pantoprazole Sodium	St. Mary's Medical Park Pharmacy \| Torrent Pharmaceuticals Limited	2019-10-15	HUMAN PRESCRIPTION DRUG LABEL	1
Pantoprazole Sodium	Clinical Solutions Wholesale, LLC	2019-07-12	HUMAN PRESCRIPTION DRUG LABEL	3
PANTOPRAZOLE SODIUM D/R	DIRECT RX	2018-12-11	HUMAN PRESCRIPTION DRUG LABEL	1
Pantoprazole Sodium	Unit Dose Services	2018-09-27	HUMAN PRESCRIPTION DRUG LABEL	3
Pantoprazole Sodium	Aphena Pharma Solutions - Tennessee, LLC	2018-07-20	HUMAN PRESCRIPTION DRUG LABEL	1
Pantoprazole Sodium	State of Florida DOH Central Pharmacy	2015-01-17	HUMAN PRESCRIPTION DRUG LABEL	2