Pantoprazole Sodium

Product NDC: 71288-600
11-digit product format: 712880600
Labeler code: 71288
Product ID: 71288-600_48bbc577-3242-4da3-bca3-7a5f89105415
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Pantoprazole Sodium
Dosage form: INJECTION, POWDER, FOR SOLUTION
Route: INTRAVENOUS
Labeler: Meitheal Pharmaceuticals Inc.
Application: ANDA215860
Marketing category: ANDA
Marketing start: 2022-08-29
Substance: PANTOPRAZOLE SODIUM
Active strength: 40 mg/10mL
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 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A215860-001	PANTOPRAZOLE SODIUM	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP		2022-08-29

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A215860-001	AP

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.

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	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215860-001	PANTOPRAZOLE SODIUM	EQ 40MG BASE/VIAL	INJECTABLE / INTRAVENOUS	AP	2022-08-29	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A215860-001	AP	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A215860-001	AP	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A215860-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215860-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215860-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215860-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215860-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215860-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215860-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215860-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215860-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215860-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215860-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215860-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215860-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215860-001	AP	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215860-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215860-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215860-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215860-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215860-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215860-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215860-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215860-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215860-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215860-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215860-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215860-001	AP	1	`e64feba35796…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215860-001	AP	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Pantoprazole Sodium
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
PANTOPRAZOLE SODIUM	40 mg/10mL

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 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
283669	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
014f9762-6948-46b7-8659-5c89f35ad8bf	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	SPL version
71288-600-10	Pantoprazole Sodium	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	10	6
71288-600-11	Pantoprazole Sodium	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	6
71288-600-91	Pantoprazole Sodium	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, POWDER, FOR SOLUTION	10	1
71288-600-92	Pantoprazole Sodium	10 in 1 CARTON	INJECTION, POWDER, FOR SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71288-600-10	EA - Each	71288-600	51d04097-e4b5-4699-baf2-a6e6be97ecac	1	2023-04-07
71288-600-11	EA - Each	71288-600	7d126adc-cb4c-4b7d-8814-1d270690ff3e	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71288-600	PANTOPRAZOLE SODIUM INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]	6	Current NDC, Legacy NDC, 2 package rows	20250514_c18aff31-f91e-4b6a-9713-52c9094c6082.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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Northstar Rx LLC	7e0c5dac-6832-4692-b012-ca59d5e88987	2026-04-08	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215860 application number: ANDA215860
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Meitheal Pharmaceuticals Inc.	014f9762-6948-46b7-8659-5c89f35ad8bf	2025-06-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215860 application number: ANDA215860 ndc (product): 71288-600
Pantoprazole Sodium	PANTOPRAZOLE SODIUM	Meitheal Pharmaceuticals Inc.	c18aff31-f91e-4b6a-9713-52c9094c6082	2025-03-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215860 application number: ANDA215860 ndc (product): 71288-600

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
283669	pantoprazole 40 MG Injection	PSN	c18aff31-f91e-4b6a-9713-52c9094c6082	6
283669	pantoprazole 40 MG Injection	SCD	c18aff31-f91e-4b6a-9713-52c9094c6082	6
283669	pantoprazole (as sodium) 40 MG Injection	SY	c18aff31-f91e-4b6a-9713-52c9094c6082	6
283669	pantoprazole 40 MG Injection	PSN	014f9762-6948-46b7-8659-5c89f35ad8bf	1
283669	pantoprazole 40 MG Injection	SCD	014f9762-6948-46b7-8659-5c89f35ad8bf	1
283669	pantoprazole (as sodium) 40 MG Injection	SY	014f9762-6948-46b7-8659-5c89f35ad8bf	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
71288-600-10	71288060010	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
71288-600-11	71288060011	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-11) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-10)		2022-08-29	0000-00-00	No	No	Current
71288-600-91	71288060091	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
71288-600-92	71288060092	10 VIAL, SINGLE-DOSE in 1 CARTON (71288-600-92) / 10 mL in 1 VIAL, SINGLE-DOSE (71288-600-91)		2022-08-29		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Pantoprazole Sodium	Meitheal Pharmaceuticals Inc. \| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	2025-06-27	HUMAN PRESCRIPTION DRUG LABEL	1
Pantoprazole Sodium	Meitheal Pharmaceuticals Inc. \| Nanjing King-Friend Biochemical Pharmaceutical Co., Ltd.	2025-03-13	HUMAN PRESCRIPTION DRUG LABEL	6