FDA.reportPublic FDA data

NDC 71288-024-20 - 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
71288-024
Requested NDC
71288-024-20
Package NDCs from labels
71288-024-20, 71288-024-21
Manufacturer
Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.
Effective date
2023-03-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Vancomycin - Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.Meitheal Pharmaceuticals Inc. | Kindos Pharmaceuticals Co., Ltd.2023-03-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-024-20Vancomycin hydrochloride15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,155
71288-024-21Vancomycin hydrochloride10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,105

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-024VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [MEITHEAL PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 2 package rows20230328_e5e26614-4119-40cc-b092-48ab97a41287.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-024-20EA - Each71288-024a1650d57-0dd8-4d57-bc15-8ca61162cb3912023-08-08
71288-024-21EA - Each71288-0244b9b8e02-4435-4ba3-ba76-cd3352f490d412023-08-08

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 3 of 4 · 74 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited65e5f2ee-934c-40d7-967c-00d085f84ffd2025-04-24Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD
vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEAdvanced Rx of Tennessee, LLC33127951-1fad-15c1-e063-6294a90a69962025-04-18Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHikma Pharmaceuticals USA Inc.b62b7190-48e8-4596-a6ad-9ad455e5c8c62025-03-21Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC9bfe30f8-c662-4af3-bc82-f0102eef89522025-03-17Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEHospira, Inc.91c050cf-3b2d-48bc-7297-e8dc68225e5a2025-01-16Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC83ea3faf-fedd-4725-911f-d71a23ec5d5e2024-10-15Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEHIKMA PHARMACEUTICALS USA INC.e4ce7b87-fab4-4b7a-b121-eba136c464ce2024-08-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VancomycinVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticals06dcfd36-942f-4752-86ad-4c5a6fc3e48f2024-07-19Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC4a80cb3f-7410-47aa-af1f-ff83d1b35c552024-07-08Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC78984781-3c0b-4b73-ba85-10d60ecb2a282024-07-08Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLC40a88420-5fcb-4715-abc5-595a18fd08d02024-06-07Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMylan Institutional LLCcaf22ccb-df75-45ea-a1d0-ccb2d37272fb2024-06-07Warnings, Adverse reactionsExact identifier
rxcui: 1807518
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEXellia Pharmaceuticals USA LLC8403695c-3614-490b-9797-6c5ebcdeef9b2023-12-12Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.45642a47-4712-4a12-8cf7-ee6c2ab8e6c62023-09-29Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDEFresenius Kabi USA, LLC0576803d-95de-4a48-806a-69ae3fcaf6b02023-08-17Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEEugia US LLC9aa42538-c84e-4886-8d3d-a7dfded5120f2023-08-05Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEGland Pharma Limited35ecffbc-77d8-4c0d-9b14-6a3cc442dec62023-07-13Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDESagent Pharmaceuticals4843726f-6e79-6e20-2620-4a54616e64792023-06-29Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin HydrochlorideVANCOMYCIN HYDROCHLORIDEAmneal Pharmaceuticals NY LLC3c47d5c4-8cdb-4701-8d7a-8a6e79025b532023-06-23Warnings, Adverse reactionsExact identifier
unii: 71WO621TJD
Vancomycin hydrochlorideVANCOMYCIN HYDROCHLORIDEMeitheal Pharmaceuticals Inc.e5e26614-4119-40cc-b092-48ab97a412872023-03-27Warnings, Adverse reactionsExact identifier
application number: ANDA215195
ndc (package): 71288-024-21
ndc (package): 71288-024-20
ndc (product): 71288-024
ndc11 (package): 71288002420
rxcui: 1807518
spl id: c050d3db-83fa-4e01-a304-db41eb41086a
spl set id: e5e26614-4119-40cc-b092-48ab97a41287
unii: 71WO621TJD

Reported adverse events (FAERS/openFDA)#

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