vancomycin hydrochloride
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 useInitial U.S. Approval: 1986
Approved
Approval ID
ab658fbd-68ea-4275-84b1-c3361c860bd3
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 14, 2023
Manufacturers
FDA
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
DUNS: 780779901
Products 2
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 Code23155-858
Application NumberANDA065490
Product Classification
M
Marketing Category
C73584
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (17)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 125 mg in 1 1
Code: 71WO621TJD
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
D&C RED NO. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
vancomycin hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code23155-859
Application NumberANDA065490
Product Classification
M
Marketing Category
C73584
G
Generic Name
vancomycin hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 14, 2023
FDA Product Classification
INGREDIENTS (14)
VANCOMYCIN HYDROCHLORIDEActive
Quantity: 250 mg in 1 1
Code: 71WO621TJD
Classification: ACTIM
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL, UNSPECIFIEDInactive
Code: 3WJQ0SDW1A
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT