FDA.reportPublic FDA data

NDC 0049-1515-01 - 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
0049-1515
Requested NDC
0049-1515-01
Package NDCs from labels
0049-1515-01, 0049-1515-02
Manufacturer
Roerig | Pharmacia & Upjohn Company LLC
Effective date
2026-07-09
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 LLC2026-07-09HUMAN 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]16
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]16
AMPICILLINACTIVE MOIETY7C782967RDUNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]16
SULBACTAMACTIVE MOIETYS4TF6I2330UNASYN (AMPICILLIN SODIUM AND SULBACTAM SODIUM) INJECTION, POWDER, FOR SOLUTION [ROERIG]16

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 · 64 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
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
unii: JFN36L5S8K
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.139b4b2e-46f7-44a8-9cc1-774afa463b802026-07-23Warnings, Adverse reactionsExact identifier
rxcui: 240984
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticalsa67ae347-487d-4751-a841-b321e81db26f2026-07-21Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
application number: NDA050608
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
application number: NDA050608
ndc (package): 0049-0024-28
ndc (package): 0049-1515-02
ndc (package): 0049-1515-01
ndc (product): 0049-0024
ndc (product): 0049-1515
ndc11 (package): 00049151501
rxcui: 205843
rxcui: 240984
spl id: 4ab1bb1d-5604-4d23-a112-77b04116e448
spl set id: 12eeb72a-403d-41be-bae4-4cb930862884
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC72a37674-8cb2-4b40-aac8-d345ffcf22f22026-06-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC9a722de6-9dc0-4fb9-b63a-225385aa33142026-06-23Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMWG Critical Care, LLC77158167-0c1e-4f01-a5b0-a3df8ad121f52026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 240984
unii: JFN36L5S8K
unii: DKQ4T82YE6
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
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
unii: DKQ4T82YE6
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
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.a65a70bf-4283-4bc0-b576-00c9ab29bd642026-03-25Warnings, Adverse reactionsExact identifier
rxcui: 240984
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6

Reported adverse events (FAERS/openFDA)#

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