FDA.reportPublic FDA data

NDC 72485-417-01 - Ampicillin Sodium and Sulbactam Sodium

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
72485-417
Requested NDC
72485-417-01
Package NDCs from labels
72485-417-01, 72485-417-10
Manufacturer
Armas Pharmaceuticals Inc. | Onesource Specialty Pte. Limited | Onesource Specialty Private Limited - Beta Lactam Division
Effective date
2025-07-31
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, USPArmas Pharmaceuticals Inc. | Onesource Specialty Pte. Limited | Onesource Specialty Private Limited - Beta Lactam Division2025-07-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72485-417-01Ampicillin Sodium and Sulbactam Sodium1 in 1 VIALINJECTION, POWDER, FOR SOLUTION14
72485-417-10Ampicillin Sodium and Sulbactam Sodium10 in 1 CARTONINJECTION, POWDER, FOR SOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-417AMPICILLIN SODIUM AND SULBACTAM SODIUM (AMPICILLIN SODIUM, SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ARMAS PHARMACEUTICALS INC.]3Current NDC, 2 package rows20241030_ac6f8158-9d7e-4b99-af3c-0407c5287b57.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-417-01EA - Each72485-41789b4dbb5-4a30-4320-97b7-e2ed45a223c512023-05-05
72485-417-10EA - Each72485-4171d805698-bd09-42f2-b7a7-31a3a31fc88612023-05-05

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
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
application number: ANDA201024
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
application number: ANDA201024
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
application number: ANDA201024
ndc (package): 72485-417-01
ndc (package): 72485-416-01
ndc (package): 72485-416-10
ndc (package): 72485-417-10
ndc (product): 72485-417
ndc (product): 72485-416
ndc11 (package): 72485041701
rxcui: 1659592
rxcui: 1659598
spl id: 44a1fdb7-5659-23bc-e063-6294a90a1ccd
spl set id: ac6f8158-9d7e-4b99-af3c-0407c5287b57
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
Ampicillin sodiumAMPICILLINCivica, Inc.2fd0f9fa-5b86-42f7-9a9f-767123638d392025-06-30Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K

Reported adverse events (FAERS/openFDA)#

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