NDC 63323-203

Vancomycin Hydrochloride

Vancomycin Hydrochloride

Vancomycin Hydrochloride is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Fresenius Kabi Usa, Llc. The primary component is Vancomycin Hydrochloride.

Product ID63323-203_2310f91c-9099-4854-b309-e649a52384f9
NDC63323-203
Product TypeHuman Prescription Drug
Proprietary NameVancomycin Hydrochloride
Generic NameVancomycin Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2016-08-17
Marketing CategoryANDA / ANDA
Application NumberANDA062663
Labeler NameFresenius Kabi USA, LLC
Substance NameVANCOMYCIN HYDROCHLORIDE
Active Ingredient Strength750 mg/15mL
Pharm ClassesGlycopeptide Antibacterial [EPC],Glycopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 63323-203-26

10 VIAL in 1 TRAY (63323-203-26) > 15 mL in 1 VIAL (63323-203-41)
Marketing Start Date2016-08-17
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-203-20 [63323020320]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-17

NDC 63323-203-01 [63323020301]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-02-11

NDC 63323-203-26 [63323020326]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-17

NDC 63323-203-41 [63323020341]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2016-08-17

Drug Details

Active Ingredients

IngredientStrength
VANCOMYCIN HYDROCHLORIDE750 mg/15mL

OpenFDA Data

SPL SET ID:f604d399-fded-4f4f-8efe-af558ed07b9d
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807518
  • 1807513
  • 1807516
  • Pharmacological Class

    • Glycopeptide Antibacterial [EPC]
    • Glycopeptides [CS]

    NDC Crossover Matching brand name "Vancomycin Hydrochloride" or generic name "Vancomycin Hydrochloride"

    NDCBrand NameGeneric Name
    0121-0867VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0121-0890VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0143-9355Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9356Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9357Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9358Vancomycin HydrochlorideVancomycin Hydrochloride
    0143-9359Vancomycin HydrochlorideVancomycin Hydrochloride
    0338-3551VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0338-3552VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0338-3580VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    0409-4332Vancomycin HydrochlorideVancomycin Hydrochloride
    68001-338Vancomycin HydrochlorideVancomycin Hydrochloride
    68001-339Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6535Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6509Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6533Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6534Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6531Vancomycin HydrochlorideVancomycin Hydrochloride
    0409-6510Vancomycin HydrochlorideVancomycin Hydrochloride
    68083-143Vancomycin HydrochlorideVancomycin Hydrochloride
    68083-144Vancomycin HydrochlorideVancomycin Hydrochloride
    68180-166VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    68180-167VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    70594-046Vancomycin HydrochlorideVancomycin Hydrochloride
    70594-048Vancomycin HydrochlorideVancomycin Hydrochloride
    70594-045Vancomycin HydrochlorideVancomycin Hydrochloride
    70860-105Vancomycin HydrochlorideVancomycin Hydrochloride
    70860-104Vancomycin HydrochlorideVancomycin Hydrochloride
    0781-3188Vancomycin HydrochlorideVancomycin Hydrochloride
    0781-3187Vancomycin HydrochlorideVancomycin Hydrochloride
    17478-741Vancomycin HydrochlorideVancomycin Hydrochloride
    17478-742Vancomycin HydrochlorideVancomycin Hydrochloride
    23155-218VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    23155-219VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    23155-217VANCOMYCIN HYDROCHLORIDEVANCOMYCIN HYDROCHLORIDE
    45932-0032Vancomycin HydrochlorideVancomycin Hydrochloride
    45932-0029Vancomycin HydrochlorideVancomycin Hydrochloride
    45932-0031Vancomycin HydrochlorideVancomycin Hydrochloride
    47781-729vancomycin hydrochloridevancomycin hydrochloride
    47781-730vancomycin hydrochloridevancomycin hydrochloride
    45932-0028Vancomycin HydrochlorideVancomycin Hydrochloride
    47781-597Vancomycin HydrochlorideVancomycin Hydrochloride
    47781-598Vancomycin HydrochlorideVancomycin Hydrochloride
    52584-332Vancomycin HydrochlorideVancomycin Hydrochloride
    51991-940Vancomycin HydrochlorideVancomycin Hydrochloride
    51991-941Vancomycin HydrochlorideVancomycin Hydrochloride
    55150-204Vancomycin HydrochlorideVancomycin Hydrochloride
    55150-203Vancomycin HydrochlorideVancomycin Hydrochloride
    55150-205Vancomycin HydrochlorideVancomycin Hydrochloride
    55150-206Vancomycin HydrochlorideVancomycin Hydrochloride

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