FDA.reportPublic FDA data

NDC 0641-6119-01 - Ampicillin and Sulbactam

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
0641-6119
Requested NDC
0641-6119-01
Package NDCs from labels
0641-6119-01, 0641-6119-10
Manufacturer
Hikma Pharmaceuticals USA Inc. | MITIM SRL
Effective date
2019-12-30
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Ampicillin and Sulbactam - Hikma Pharmaceuticals USA Inc. | MITIM SRLHikma Pharmaceuticals USA Inc. | MITIM SRL2019-12-30HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0641-6119-102025-03-12C16284748780-12cef2736-82c7-d83d-e063-dadaa90ab31fAMPICILLIN AND SULBACTAM FOR INJECTION, USP
0641-6119-102025-01-30C16284748780-12cef2736-82c7-d83d-e063-dadaa90ab31fAMPICILLIN AND SULBACTAM FOR INJECTION, USP

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0641-6119-01EA - Each0641-6119895d1de9-7a6b-4e1f-a91a-b231de77c99c12012-07-24
0641-6119-10EA - Each0641-6119da754f59-e84b-4e95-b355-e4a260d49d9612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AMPICILLIN SODIUMACTIVE INGREDIENTJFN36L5S8KAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
SULBACTAM SODIUMACTIVE INGREDIENTDKQ4T82YE6AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
AMPICILLINACTIVE MOIETY7C782967RDAMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4
SULBACTAMACTIVE MOIETYS4TF6I2330AMPICILLIN AND SULBACTAM INJECTION, POWDER, FOR SOLUTION [WEST-WARD PHARMACEUTICAL CORP.]4

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
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
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN SODIUM AND SULBACTAM SODIUMMeitheal Pharmaceuticals Inc.006f9a3f-b4e3-4aa5-ac65-6cc3d3e2582d2026-07-22Warnings, Adverse reactionsExact identifier
application number: ANDA065406
unii: JFN36L5S8K
unii: DKQ4T82YE6
ampicillin and sulbactamAMPICILLIN AND SULBACTAMSagent Pharmaceuticalsa67ae347-487d-4751-a841-b321e81db26f2026-07-21Warnings, Adverse reactionsExact identifier
application number: ANDA065406
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig155c7ec0-5862-404f-b1d0-f278f8a8bbda2026-07-10Warnings, Adverse reactionsExact identifier
unii: JFN36L5S8K
unii: DKQ4T82YE6
UNASYNAMPICILLIN SODIUM AND SULBACTAM SODIUMRoerig12eeb72a-403d-41be-bae4-4cb9308628842026-07-09Warnings, Adverse reactionsExact identifier
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
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
application number: ANDA065406
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
unii: JFN36L5S8K
unii: DKQ4T82YE6
Ampicillin and SulbactamAMPICILLIN AND SULBACTAMHikma Pharmaceuticals USA Inc.d3026cc0-95d8-44cf-be47-b5ebb8fd45682026-03-25Warnings, Adverse reactionsExact identifier
application number: ANDA065406
unii: JFN36L5S8K
unii: DKQ4T82YE6

Reported adverse events (FAERS/openFDA)#

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