FDA.reportPublic FDA data

NDC 0781-9409-46 - 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
0781-9409
Requested NDC
0781-9409-46
Package NDCs from labels
0781-9409-46, 0781-9409-95
Manufacturer
Sandoz Inc
Effective date
2024-05-09
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin - Sandoz IncSandoz Inc2024-05-09HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0781-9409-46Ampicillin1 in 1 VIAL, PHARMACY BULK PACKAGEINJECTION, POWDER, FOR SOLUTION119
0781-9409-95Ampicillin10 in 1 PACKAGEINJECTION, POWDER, FOR SOLUTION1019

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0781-9409AMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]19Current NDC, Legacy NDC, 2 package rows20240518_5308ddfa-4a5b-4f7b-83ce-9d1b528e050d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0781-9409-46EA - Each0781-94092f852894-ccf7-4610-8c02-69677603d88612016-03-04
0781-9409-95EA - Each0781-940978517ba7-3c9a-4bda-acc9-592f3abcd4af12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN (AMPICILLIN SODIUM) INJECTION, POWDER, FOR SOLUTION [SANDOZ INC]14

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 3 of 4 · 62 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLIN SODIUMSandoz Inc67dd2930-8482-4da5-b663-b751aff18c612025-05-16Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC577dd6f0-d56a-4c82-9f72-274c3a4a0f012025-04-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMAvenacy, LLC4446d4c8-056d-4bc3-8f58-21255b0633982025-04-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Inc64a04e8c-8f78-46b3-8f45-56ef225a4f742025-02-21Warnings, Adverse reactionsExact identifier
application number: ANDA061395
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMAvenacy Inc.19546563-50b7-4160-8cbe-f8e7079cba692025-02-01Warnings, Adverse reactionsExact identifier
rxcui: 789980
unii: JFN36L5S8K
AmpicillinAMPICILLINMedical Purchasing Solutions, LLC29675d9c-3248-337a-e063-6294a90a2e202024-12-16Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticals35606b43-5914-423c-9bc7-fa3957eb25632024-11-18Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Incc2908a44-1da4-4885-ae5a-23f69189d91a2024-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA061395
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Incb371e1a5-1fef-4df2-8940-c4fc02b9e2f02024-10-31Warnings, Adverse reactionsExact identifier
application number: ANDA061395
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC5e8d35cb-e93d-42ad-a02c-0dbf04910f612024-08-13Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMNorthStar Rx, LLC1e5004f1-e79e-4e0b-9f3f-25f6bbc152552024-06-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Inc5308ddfa-4a5b-4f7b-83ce-9d1b528e050d2024-05-09Warnings, Adverse reactionsExact identifier
application number: ANDA061395
ndc (package): 0781-9409-95
ndc (package): 0781-9409-46
ndc (product): 0781-9409
ndc11 (package): 00781940946
rxcui: 789980
spl id: 86e9a3cc-bc65-4d4f-916d-98c916588730
spl set id: 5308ddfa-4a5b-4f7b-83ce-9d1b528e050d
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Inc6632a5bd-45f1-422f-80b0-46e5a628969a2024-05-08Warnings, Adverse reactionsExact identifier
application number: ANDA061395
rxcui: 789980
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMSandoz Incf77db491-31c4-4a7c-a114-0f3244c970902024-05-07Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMNorthStar Rx, LLC6772d650-9814-49e4-a4ec-0b1a97b837d12024-02-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirste47a21b1-bbdb-4321-e053-2a95a90a3b4a2024-01-28Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AMPICILLINAMPICILLINHF Acquisition Co LLC, DBA HealthFirste51db6a3-027a-6e24-e053-2a95a90a15872024-01-14Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC690f1986-6da9-4787-e053-2a91aa0a26442023-05-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLIN SODIUMMedical Purchasing Solutions, LLC70c022b0-ac9a-409b-e053-2a91aa0a757e2023-05-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
AmpicillinAMPICILLINMedical Purchasing Solutions, LLCbbf118c0-7cd3-5a82-e053-2a95a90ac8c82023-05-08Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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