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 1 of 4 · 65 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.78988f6a-a73b-4d3b-9a76-d61a748c3c162026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin SodiumAMPICILLIN SODIUMSagent Pharmaceuticals5b3796dd-6f81-4999-ae2b-a13a727957292026-07-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillinAMPICILLINSagent Pharmaceuticals9d2aebe8-4f04-49dd-b1e5-80b962868dc32026-07-27Warnings, Adverse reactionsExact identifier
application number: ANDA090354
rxcui: 1721475
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.139b4b2e-46f7-44a8-9cc1-774afa463b802026-07-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticalsa67ae347-487d-4751-a841-b321e81db26f2026-07-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC72a37674-8cb2-4b40-aac8-d345ffcf22f22026-06-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC77158167-0c1e-4f01-a5b0-a3df8ad121f52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINWG Critical Care, LLC12b6ac82-ca74-4f88-99ea-ae4a1c419b702026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINWG Critical Care, LLC38ec7b7a-9caf-45f2-88a1-0f78f089a1e42026-06-22Warnings, Adverse reactionsExact identifier
application number: ANDA090354
rxcui: 1721475
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC3b683547-48ac-48ca-8fd4-6866fd17be342026-06-15Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.e6cf14a8-3ed9-4a7a-ba69-be0b794cbdc42026-06-10Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f3ba6-606f-bfc4-e063-6294a90af8842026-05-12Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLIN SODIUMHenry Schein, Inc.06ca924c-5f3a-4924-90f4-5ba623daaa0e2026-04-30Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMedical Purchasing Solutions, LLC.4e81c215-2ab6-87c6-e063-6294a90ac28c2026-04-02Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.a65a70bf-4283-4bc0-b576-00c9ab29bd642026-03-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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