vancomycin hydrochloride
Vancomycin HCl Capsule These highlights do not include all the information needed to use VANCOMYCIN HYDROCHLORIDE CAPSULES safely and effectively. See full prescribing information for VANCOMYCIN HYDROCHLORIDE CAPSULES. VANCOMYCIN HYDROCHLORIDE capsules, for oral use Initial U.S. Approval: 1986
Approved
Approval ID
33127951-1fad-15c1-e063-6294a90a6996
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Advanced Rx of Tennessee, LLC
DUNS: 117023142
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
vancomycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80425-0514
Application NumberNDA050606
Product Classification
M
Marketing Category
C73605
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (7)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
POLYETHYLENE GLYCOL 6000Inactive
Code: 30IQX730WE
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 71WO621TJD
Classification: ACTIM
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 4/18/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 4/18/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 4/18/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 4/18/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 4/18/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 4/18/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 4/18/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 4/18/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 4/18/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 4/18/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 4/18/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 4/18/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 4/18/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 4/18/2025
CLINICAL STUDIES SECTION
LOINC: 34092-7Updated: 4/18/2025
REFERENCES SECTION
LOINC: 34093-5Updated: 4/18/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 4/18/2025
INFORMATION FOR PATIENTS SECTION
LOINC: 34076-0Updated: 4/18/2025