FDA.reportPublic FDA data

NDC 0143-9355-01 - 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
0143-9355
Requested NDC
0143-9355-01
Package NDCs from labels
0143-9355-01, 0143-9355-10
Manufacturer
Hikma Pharmaceuticals USA Inc.
Effective date
2022-02-25
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.2022-02-25HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9355-01Vancomycin Hydrochloride1 in 1 VIALINJECTION, POWDER, LYOPHILIZED,14
0143-9355-10Vancomycin Hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0143-9355VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HIKMA PHARMACEUTICALS USA INC.]4Current NDC, Legacy NDC, 2 package rows20220304_86950e7c-0114-47e9-8891-e09e595c48c3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9355-01EA - Each0143-93555d2ce172-3a6c-46b5-a04f-0179751bc0ea12019-05-02
0143-9355-10EA - Each0143-93558354e7fd-4deb-4915-8894-9ab70c2381ee12019-05-02

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 1 ยท 14 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TYZAVANVANCOMYCINHikma Pharmaceuticals USA Inc.72e9c5e2-07cc-4a8b-ba64-b2e7619ea5602026-08-19Warnings, Adverse reactionsExact identifier
unii: 6Q205EH1VU
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAvenacy, LLCc757e65b-ca6f-4c00-afe2-025962b43d312026-07-31Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.f2901045-904f-47bd-74a1-c561facd7f252026-04-01Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGLENMARK PHARMACEUTICALS INC., USA0543b2b5-b1c7-4ad6-b38c-3be0086f0e062025-12-23Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESTERISCIENCE SPECIALTIES PRIVATE LIMITED2c355037-6a1e-4846-872a-471ccbdc8d542025-10-31Warnings, Adverse reactionsExact identifier
rxcui: 1807518
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INC.8eccafe8-40c9-495a-872d-7f45a98ee7592025-08-13Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticalsf623889c-a47a-4b3a-b3a9-e04051f5c2df2025-05-28Warnings, Adverse reactionsExact identifier
rxcui: 1807518
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLCf604d399-fded-4f4f-8efe-af558ed07b9d2025-05-15Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited65e5f2ee-934c-40d7-967c-00d085f84ffd2025-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC9bfe30f8-c662-4af3-bc82-f0102eef89522025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCcaf22ccb-df75-45ea-a1d0-ccb2d37272fb2024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 1807518
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.e5e26614-4119-40cc-b092-48ab97a412872023-03-27Warnings, Adverse reactionsExact identifier
rxcui: 1807518
VancomycinVANCOMYCINXellia Pharmaceuticals USA LLC60bee69b-be70-412c-9e83-a24a0a8a5e7b2023-03-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 6Q205EH1VU
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.86950e7c-0114-47e9-8891-e09e595c48c32022-02-25Warnings, Adverse reactionsExact identifier
application number: ANDA206616
ndc (package): 0143-9355-01
ndc (package): 0143-9355-10
ndc (product): 0143-9355
ndc11 (package): 00143935501
rxcui: 1807518
spl id: e298d434-6e7e-4a46-9744-a098386a89d6
spl set id: 86950e7c-0114-47e9-8891-e09e595c48c3
unii: 6Q205EH1VU

Reported adverse events (FAERS/openFDA)#

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