FDA.reportPublic FDA data

NDC 0143-9357-01 - Vancomycin Hydrochloride

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
0143-9357
Requested NDC
0143-9357-01
Package NDCs from labels
0143-9357-01, 0143-9357-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2021-06-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin Hydrochloride for Injection, USPHikma Pharmaceuticals USA Inc.2021-06-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9357-01Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,15
0143-9357-10Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9357VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 2 package rows20210605_2f5d3131-8ddc-43a5-91f7-947c531796e7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9357-01EA - Each0143-93574b932046-2cd4-4e98-b531-372ef227405812022-09-12
0143-9357-10EA - Each0143-93570ec21d56-69c7-40be-8dec-7f1167c315c612022-09-12

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 4 of 4 · 73 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC0713a847-a334-4b73-af22-343aa06621b92023-02-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC8a35ebee-8650-4ef5-84f5-ab9b55d9bc192022-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLC418c3c6a-d08d-448c-89c9-54e558c1ce162022-12-02Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEBluePoint Laboratoriesf28e3c2b-ae31-4c2a-8178-53962b7b213c2022-09-22Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDECamber Pharmaceuticals, Inc.3f5dacea-af40-4103-b128-c5e0c0c52fa12022-07-20Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.cae9e5f3-b89a-4a7f-93f7-9471c74a35592021-12-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCd3147f2d-1a72-4923-874b-8fdee2be625e2021-09-30Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCce139a51-0471-4c31-b456-2f889f18dd2b2021-09-15Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.2f5d3131-8ddc-43a5-91f7-947c531796e72021-06-02Warnings, Adverse reactionsExact identifier
application number: ANDA203300
ndc (package): 0143-9357-10
ndc (package): 0143-9356-01
ndc (package): 0143-9356-25
ndc (package): 0143-9357-01
ndc (product): 0143-9357
ndc (product): 0143-9356
ndc11 (package): 00143935701
rxcui: 1807513
rxcui: 1807516
spl id: 431d7445-e798-40a7-a8aa-6a8b1ac5813f
spl set id: 2f5d3131-8ddc-43a5-91f7-947c531796e7
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC2dc7b3d6-3874-40ac-b8aa-7bcfe2dc0cdf2021-06-01Warnings, Adverse reactionsExact identifier
rxcui: 1807513
rxcui: 1807516
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC3843d0d7-f70a-4b29-9478-dfb45b02425e2021-06-01Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESAMSON MEDICAL TECHNOLOGIES LLC93589e71-3a11-4797-9176-8abdb7674a872020-11-29Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi, LLCa7e7d990-1d74-459b-ac07-d1c3e13b32042019-01-09Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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