FDA.reportPublic FDA data

NDC 0463-1118-10 - Ampicillin

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
0463-1118
Requested NDC
0463-1118-10
Package NDCs from labels
0463-1118-10, 0463-1118-11
Manufacturer
C.O. Truxton, Inc. | ACIC Fine Chemicals | Antibiotice SA
Effective date
2010-06-25
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin - C.O. Truxton, Inc. | ACIC Fine Chemicals | Antibiotice SAC.O. Truxton, Inc. | ACIC Fine Chemicals | Antibiotice SA2010-06-25HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0463-1118-112019-10-21C16284748780-1956f9ecf-bf58-621f-e053-dbdaa90a74adAmpicillin for Injection, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0463-1118-10Ampicillin1 in 1 VIALINJECTION, POWDER, FOR SOLUTION11
0463-1118-11Ampicillin10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0463-1118AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [C.O. TRUXTON, INC.]1Legacy NDC, 2 package rows20100629_93ae42af-f4b4-4858-a891-fe76c82bd3f9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Ampicillin SodiumACTIVE INGREDIENTJFN36L5S8KAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [C.O. TRUXTON, INC.]1
AmpicillinACTIVE MOIETY7C782967RDAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [C.O. TRUXTON, INC.]1

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 2 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMHospira, Incdc374fa4-350b-425d-a7db-7099fdc64cf12026-01-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC437a26f4-776b-4f74-99b2-09ad79831b0c2025-12-18Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLINCivica, Inc.a194f310-a669-4d8f-8c04-ee9ca01939b12025-12-09Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED573aca0c-111e-4ed3-9bcd-18136cae12cc2025-11-28Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillin sodium and sulbactam sodiumAMPICILLIN SODIUM AND SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED44181723-ef09-301b-e063-6394a90a2cad2025-11-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLIN INJECTIONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.302e6df7-37c5-4625-8a61-3e2f302addf22025-11-07Warnings, Adverse reactionsExact identifier
application number: ANDA090354
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC16fdfdb9-9e26-48d0-8838-570d30c8e8972025-11-04Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.409f8a6d-f54f-415f-994c-ecd2b820caab2025-10-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.65d94837-ca25-4728-932b-139d3bf4c7162025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillin sodium and sulbactam sodiumAMPICILLIN SODIUM AND SULBACTAM SODIUMCivica, Inc.e98a36a1-b75b-42b9-ad1a-05004e9587b62025-09-08Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMEugia US LLC66146d45-0fe4-46b9-b2b1-b67c219088b72025-08-14Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLCadc92303-b62b-41c8-becf-9c3a4e8c3a6b2025-08-12Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC2709e9fc-2341-4382-af72-c2e3201bd77a2025-08-12Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.ac6f8158-9d7e-4b99-af3c-0407c5287b572025-07-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.34e95c91-3767-493c-8716-38e61e7c66742025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.9f2ff165-2a21-4155-a4f0-57885a83c7dc2025-07-24Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin sodiumAMPICILLINCivica, Inc.2fd0f9fa-5b86-42f7-9a9f-767123638d392025-06-30Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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