FDA.reportPublic FDA data

NDC 0049-3003-01 - UNASYN

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
0049-3003
Requested NDC
0049-3003-01
Package NDCs from labels
0049-3003-01, 0049-3003-10
Manufacturer
Roerig | Pharmacia & Upjohn Company LLC
Effective date
2026-07-10
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
UNASYN - Roerig | Pharmacia & Upjohn Company LLCRoerig | Pharmacia & Upjohn Company LLC2026-07-10HUMAN PRESCRIPTION DRUG LABEL

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KUNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
AMPICILLINACTIVE MOIETY7C782967RDUNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13
SULBACTAMACTIVE MOIETYS4TF6I2330UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]13

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 · 64 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AmpicillinAMPICILLINONESOURCE SPECIALTY PHARMA LIMITED519f2131-79e7-569f-e063-6394a90a2f932026-02-27Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMHospira, Incdc374fa4-350b-425d-a7db-7099fdc64cf12026-01-21Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC437a26f4-776b-4f74-99b2-09ad79831b0c2025-12-18Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AMPICILLINAMPICILLINCivica, Inc.a194f310-a669-4d8f-8c04-ee9ca01939b12025-12-09Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED573aca0c-111e-4ed3-9bcd-18136cae12cc2025-11-28Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
ampicillin sodium and sulbactam sodiumAMPICILLIN SODIUM AND SULBACTAM SODIUMONESOURCE SPECIALTY PHARMA LIMITED44181723-ef09-301b-e063-6394a90a2cad2025-11-21Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
AMPICILLINAMPICILLIN INJECTIONHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.302e6df7-37c5-4625-8a61-3e2f302addf22025-11-07Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC16fdfdb9-9e26-48d0-8838-570d30c8e8972025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.409f8a6d-f54f-415f-994c-ecd2b820caab2025-10-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.65d94837-ca25-4728-932b-139d3bf4c7162025-10-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin sodiumAMPICILLIN SODIUMMedical Purchasing Solutions, LLC402e7cc7-5ae8-c113-e063-6394a90aa54a2025-10-02Warnings, 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
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLIN SODIUMEugia US LLCb7bf2897-8272-4c7d-84e9-6fbba0ea63fa2025-08-14Warnings, Adverse reactionsExact identifier
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
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMEugia US LLC2709e9fc-2341-4382-af72-c2e3201bd77a2025-08-12Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin Sodium and Sulbactam SodiumAMPICILLIN SODIUM, SULBACTAM SODIUMArmas Pharmaceuticals Inc.ac6f8158-9d7e-4b99-af3c-0407c5287b572025-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1659592
rxcui: 1659598
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLINArmas Pharmaceuticals Inc.34e95c91-3767-493c-8716-38e61e7c66742025-07-31Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.9f2ff165-2a21-4155-a4f0-57885a83c7dc2025-07-24Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
AmpicillinAMPICILLIN SODIUMProPharma Distribution364b1db9-e523-7bae-e063-6294a90a651d2025-07-18Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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