FDA.reportPublic FDA data

Pantoprazole Sodium

Product NDC
73043-020
11-digit product format
730430020
Labeler code
73043
Product ID
73043-020_ee61b559-2d9b-4202-b9de-e37ce3733019
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pantoprazole Sodium
Dosage form
INJECTION, POWDER, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Devatis Inc.
Application
ANDA215074
Marketing category
ANDA
Marketing start
2025-08-01
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 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A215074-001PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2025-05-16

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A215074-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A215074-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2025-05-16011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215074-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2025-05-1631067a03dcf5…
2025-08-23 18:47 UTC2025-08A215074-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2025-05-166a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215074-001PANTOPRAZOLE SODIUMEQ 40MG BASE/VIALINJECTABLE / INTRAVENOUSAP2025-05-16a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A215074-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A215074-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A215074-001AP16a471c1ec25d…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A215074-001AP1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PANTOPRAZOLE SODIUM40 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6871619Q5XInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
283669Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
13c337e7-1e7b-47bd-9f88-92b0d548ca9cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ae9ebba7-ac9e-4a6e-90ef-4bd9760ec041Product name820260304
41d62193-73fc-49cf-9907-add9588e2da1Product name920260112
f12d0d0d-c068-46c6-872c-96c9d38533bbProduct name120250116
edf5fdf1-aed1-42ea-b2a8-97b779f9aca4Product name120230718

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73043-020-01Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-01Pantoprazole Sodium1 in 1 CARTONINJECTION, POWDER, FOR SOLUTION12
73043-020-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102
73043-020-10Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-25Pantoprazole Sodium10 mL in 1 VIALINJECTION, POWDER, FOR SOLUTION102
73043-020-25Pantoprazole Sodium25 in 1 CARTONINJECTION, POWDER, FOR SOLUTION252

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73043-020-01EA - Each73043-020a35607f3-1cd5-4e22-b133-ac5bc344265712025-09-12
73043-020-10EA - Each73043-02041f79146-1d44-4b55-861b-a8b50e6a143812025-09-12
73043-020-25EA - Each73043-020d71e367e-69f4-4fea-87d0-a1a2cb1e57bc12025-09-12

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMDevatis Inc.13c337e7-1e7b-47bd-9f88-92b0d548ca9c2025-07-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 215074
application number: ANDA215074
ndc (product): 73043-020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283669pantoprazole 40 MG InjectionPSN13c337e7-1e7b-47bd-9f88-92b0d548ca9c2
283669pantoprazole 40 MG InjectionSCD13c337e7-1e7b-47bd-9f88-92b0d548ca9c2
283669pantoprazole (as sodium) 40 MG InjectionSY13c337e7-1e7b-47bd-9f88-92b0d548ca9c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
73043-020-01730430020011 VIAL in 1 CARTON (73043-020-01) / 10 mL in 1 VIAL1 vial2025-08-01NoNoCurrent
73043-020-107304300201010 VIAL in 1 CARTON (73043-020-10) / 10 mL in 1 VIAL10 vial2025-08-01NoNoCurrent
73043-020-257304300202525 VIAL in 1 CARTON (73043-020-25) / 10 mL in 1 VIAL25 vial2025-08-01NoNoCurrent