FDA.reportPublic FDA data

NDC 71288-031-91 - Ampicillin and Sulbactam

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
71288-031
Requested NDC
71288-031-91
Package NDCs from labels
71288-031-91, 71288-031-92, 71288-031-20, 71288-031-21
Manufacturer
Meitheal Pharmaceuticals Inc.
Effective date
2026-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin and Sulbactam - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-07-22HUMAN PRESCRIPTION DRUG LABEL
Ampicillin and Sulbactam - Meitheal Pharmaceuticals Inc.Meitheal Pharmaceuticals Inc.2026-06-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-031-20Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION16
71288-031-21Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION106
71288-031-91Ampicillin and Sulbactam1 in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, FOR SOLUTION12
71288-031-92Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-031AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, 2 package rows20250323_e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc4.zip
71288-031AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]1Current NDC, 2 package rows20240524_006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-031-20EA - Each71288-031c929ba34-0c4d-4f42-ab1a-f71c6e3106f712023-09-05
71288-031-21EA - Each71288-031aa6724ba-18bc-43a8-87b1-b47fc15d79fb12023-09-05
71288-031-91EA - Each71288-0310b923ff9-c34b-4b6d-8ed6-5af31642e20012024-09-09
71288-031-92EA - Each71288-031a8cb77d6-6828-44f4-90b3-68b30e469df912024-09-09

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 4 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLINMedical Purchasing Solutions, LLCc4310ee5-cbd3-99b5-e053-2995a90ae2292023-04-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMFresenius Kabi USA, LLC8dbb4c71-8543-08f1-e053-2995a90af88d2022-10-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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