FDA.reportPublic FDA data

NDC 0641-6116-01 - 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
0641-6116
Requested NDC
0641-6116-01
Package NDCs from labels
0641-6116-01, 0641-6116-10
Manufacturer
Hikma Pharmaceuticals USA Inc. | Mitim S.r.l.
Effective date
2026-03-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin and Sulbactam for Injection, USPHikma Pharmaceuticals USA Inc. | Mitim S.r.l.2026-03-25HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0641-6116-01Ampicillin and Sulbactam1.5 g in 1 VIALINJECTION, POWDER, FOR SOLUTION1.510
0641-6116-10Ampicillin and Sulbactam10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION1010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0641-6116AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]10Current NDC, Legacy NDC, 2 package rows20240926_d3026cc0-95d8-44cf-be47-b5ebb8fd4568.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6116-01EA - Each0641-6116b4cf2188-5d96-4b7d-8bc5-0d0c3f1af88912012-07-24
0641-6116-10EA - Each0641-6116aaf9f992-279d-44c9-995d-d236c0bc77f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
SULBACTAMACTIVE MOIETYS4TF6I2330AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4

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.