NDC 63323-221

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, Llc. The primary component is Vancomycin Hydrochloride.

Product ID63323-221_0ab54d7b-de6b-412f-b2b5-a8522f78f3c4
NDC63323-221
Product TypeHuman Prescription Drug
Proprietary NameVancomycin Hydrochloride
Generic NameVancomycin Hydrochloride
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2017-11-01
Marketing CategoryANDA / ANDA
Application NumberANDA204107
Labeler NameFresenius Kabi, LLC
Substance NameVANCOMYCIN HYDROCHLORIDE
Active Ingredient Strength500 mg/10mL
Pharm ClassesGlycopeptide Antibacterial [EPC], Glycopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 63323-221-38

25 VIAL in 1 TRAY (63323-221-38) > 10 mL in 1 VIAL (63323-221-33)
Marketing Start Date2017-11-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 63323-221-43 [63323022143]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-26

NDC 63323-221-33 [63323022133]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-01

NDC 63323-221-38 [63323022138]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-11-01

NDC 63323-221-10 [63323022110]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-09-01
Marketing End Date2019-05-31

NDC 63323-221-01 [63323022101]

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

NDC 63323-221-16 [63323022116]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA062663
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2000-09-01
Marketing End Date2019-03-31

NDC 63323-221-48 [63323022148]

VANCOMYCIN HYDROCHLORIDE INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA204107
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2017-10-26

Drug Details

Active Ingredients

IngredientStrength
VANCOMYCIN HYDROCHLORIDE500 mg/10mL

OpenFDA Data

SPL SET ID:418c3c6a-d08d-448c-89c9-54e558c1ce16
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1807513
  • 1807516
    • UPC Code
  • 0363323221430
  • 0363323284411

    • 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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