FDA.reportPublic FDA data

NDC 0143-9300-01 - Pantoprazole Sodium

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
0143-9300
Requested NDC
0143-9300-01
Package NDCs from labels
0143-9300-01, 0143-9300-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2023-07-19
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Pantoprazole Sodium - Hikma Pharmaceuticals USA Inc.Hikma Pharmaceuticals USA Inc.2023-07-19HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9300-01Pantoprazole Sodium1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,18
0143-9300-10Pantoprazole Sodium10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9300PANTOPRAZOLE SODIUM INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]8Current NDC, Legacy NDC, 2 package rows20231031_1e102c44-232b-4aaf-b457-2a740c47193a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9300-01EA - Each0143-9300002a7e38-11dc-401f-a3e3-8016fcd74b9812018-03-08
0143-9300-10EA - Each0143-9300abb7b646-531e-45b7-86f2-2b734d73fc1412018-03-08

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 7 of 7 · 136 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pantoprazole SodiumPANTOPRAZOLE SODIUMCamber Pharmaceuticals, Inc.ee6278c0-d8c0-417c-a65c-b522ff76fe442023-11-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PantoprazolePANTOPRAZOLEDr.Reddy's Laboratories Limited564709e8-358f-c185-4ecb-b3849c3fe59c2023-08-30Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMMylan Pharmaceuticals Inc.56ad5b97-8e5f-48a5-b2ba-a5484b43d0182023-08-15Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLE SODIUMSun Pharmaceutical Industries, Inc.38353b9e-63bd-47e8-b7cb-b198d1e901f92023-08-03Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMA-S Medication Solutionsf1eb666a-120d-47fd-8c9f-73cef839294a2023-07-31Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMLannett Company, Inc.e7705bf6-e473-4b9c-bb5d-57e26ffe7b972023-07-21Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.1e102c44-232b-4aaf-b457-2a740c47193a2023-07-19Warnings, Adverse reactionsExact identifier
application number: NDA209463
ndc (package): 0143-9300-01
ndc (package): 0143-9300-10
ndc (product): 0143-9300
ndc11 (package): 00143930001
rxcui: 283669
spl id: 673b147b-f117-4f86-b22c-e78ea92fb0e8
spl set id: 1e102c44-232b-4aaf-b457-2a740c47193a
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMHikma Pharmaceuticals USA Inc.b02f3f85-8f9b-4d06-8eae-73e592626f3e2023-07-10Warnings, Adverse reactionsExact identifier
application number: NDA209463
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCc10e9c12-e39d-4b0b-bd4c-10d3e9a4cf342023-02-17Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEXLCare Pharmaceuticals Inc.17468dbf-84b6-4c53-9ad5-341350d2cfab2023-01-17Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEAphena Pharma Solutions - Tennessee, LLCe3f711d8-b9d3-46a6-8bf9-6af1cc77003e2022-07-15Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMProficient Rx LPa03aa46f-9eb5-4cf4-addf-745d94af82612022-06-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LPa7dc4321-331d-49af-976c-cfd69d0055d92022-05-02Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLE SODIUMNovadoz Pharmaceuticals LLC1172bc4e-1700-402f-8262-97f05bac0d092022-03-03Warnings, Adverse reactionsExact identifier
rxcui: 283669
unii: 6871619Q5X
PANTOPRAZOLE SODIUMPANTOPRAZOLEProficient Rx LPdce2e97a-cd92-46b9-9444-91739bdcd5262019-11-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X
Pantoprazole SodiumPANTOPRAZOLEProficient Rx LP6d03491f-20c6-4878-9741-2e21e221eff22019-11-01Warnings, Adverse reactionsExact identifier
unii: 6871619Q5X

Reported adverse events (FAERS/openFDA)#

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