PANTOPRAZOLE SODIUM

Product NDC: 0338-9646
11-digit product format: 003389646
Labeler code: 0338
Product ID: 0338-9646_290e26a2-61f1-4840-9819-205212c7d365
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium in 0.9% Sodium Chloride
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Baxter Healthcare Corporation
Application: NDA217512
Marketing category: NDA
Marketing start: 2024-02-14
Substance: PANTOPRAZOLE SODIUM
Active strength: 40 mg/50mL
Pharmacologic classes: Proton Pump Inhibitor [EPC], Proton Pump Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	RLD / RS	Approval date
N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	PANTOPRAZOLE SODIUM	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14
N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	PANTOPRAZOLE SODIUM	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14
N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	PANTOPRAZOLE SODIUM	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14

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 2 · 48 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217512-002	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/50ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N217512-003	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 80MG BASE/100ML (EQ 0.8MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N217512-001	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	EQ 40MG BASE/100ML (EQ 0.4MG BASE/ML)	SOLUTION / INTRAVENOUS	RLD, RS	2024-02-14	`8072bd15b7f6…`

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/50mL

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 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2675781	Internal RxNorm lookup
2675784	Internal RxNorm lookup
2675786	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
a476e063-9450-4793-9a22-16b0a0a61cd0	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
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0338-9646-01	PANTOPRAZOLE SODIUM	50 mL in 1 BAG	INJECTION, SOLUTION	50		4
0338-9646-24	PANTOPRAZOLE SODIUM	24 in 1 CARTON	INJECTION, SOLUTION	24		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0338-9646-01	ML - Milliliter	0338-9646	9598eee4-49fc-44f6-8d68-983f8395a7a7	1	2024-12-10
0338-9646-24	ML - Milliliter	0338-9646	31916719-18fe-4e26-b2e7-79cacee399db	1	2024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0338-9646	PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE) INJECTION, SOLUTION [BAXTER HEALTHCARE CORPORATION]	4	Current NDC, 2 package rows	20250109_a476e063-9450-4793-9a22-16b0a0a61cd0.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE	Baxter Healthcare Company	a476e063-9450-4793-9a22-16b0a0a61cd0	2024-02-14	Warnings, Adverse reactions	Exact identifier application applno (NDA): 217512 application number: NDA217512 ndc (product): 0338-9646

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
2675781	pantoprazole 40 MG in 100 ML Injection	PSN	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675784	pantoprazole 40 MG in 50 ML Injection	PSN	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675786	pantoprazole 80 MG in 100 ML Injection	PSN	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675781	100 ML pantoprazole 0.4 MG/ML Injection	SCD	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675786	100 ML pantoprazole 0.8 MG/ML Injection	SCD	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675784	50 ML pantoprazole 0.8 MG/ML Injection	SCD	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675781	pantoprazole (as sodium) 40 MG per 100 ML Injection	SY	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675784	pantoprazole (as sodium) 40 MG per 50 ML Injection	SY	a476e063-9450-4793-9a22-16b0a0a61cd0	4
2675786	pantoprazole (as sodium) 80 MG per 100 ML Injection	SY	a476e063-9450-4793-9a22-16b0a0a61cd0	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
0338-9646-01	00338964601	50 mL in 1 BAG	50 ml				Historical
0338-9646-24	00338964624	24 BAG in 1 CARTON (0338-9646-24) / 50 mL in 1 BAG (0338-9646-01)	24 bag	2024-02-14	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PANTOPRAZOLE SODIUM	Baxter Healthcare Company \| Baxter Healthcare Corporation	2024-02-14	HUMAN PRESCRIPTION DRUG LABEL	5