NDC 16714-892

Daptomycin

Daptomycin

Daptomycin is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Northstar Rxllc. The primary component is Daptomycin.

Product ID16714-892_103c12d6-9b0f-a58c-0159-41fc80b4aec5
NDC16714-892
Product TypeHuman Prescription Drug
Proprietary NameDaptomycin
Generic NameDaptomycin
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2022-06-13
Marketing CategoryANDA / ANDA
Application NumberANDA208375
Labeler NameNorthStar RxLLC
Substance NameDAPTOMYCIN
Active Ingredient Strength50 mg/mL
Pharm ClassesLipopeptide Antibacterial [EPC], Lipopeptides [CS]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 16714-892-01

1 VIAL, SINGLE-DOSE in 1 CARTON (16714-892-01) > 15 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2022-06-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16714-892-01 [16714089201]

Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA208375
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-05-15

NDC 16714-892-11 [16714089211]

Daptomycin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryANDA
Application NumberANDA208375
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-05-15
Marketing End Date2019-07-03

Drug Details

Active Ingredients

IngredientStrength
DAPTOMYCIN50 mg/mL

OpenFDA Data

SPL SET ID:1c5dee92-299e-26f6-6332-e6a8fd376526
Manufacturer
UNII
UPC Code
  • 0316714892016
  • Pharmacological Class

    • Lipopeptide Antibacterial [EPC]
    • Lipopeptides [CS]

    NDC Crossover Matching brand name "Daptomycin" or generic name "Daptomycin"

    NDCBrand NameGeneric Name
    0143-9378DaptomycinDaptomycin
    0409-0106DaptomycinDAPTOMYCIN
    0409-0120DaptomycinDAPTOMYCIN
    0409-0122DaptomycinDAPTOMYCIN
    0409-2757DaptomycinDAPTOMYCIN
    0409-5933DaptomycinDaptomycin
    0703-0125DaptomycinDaptomycin
    0781-3295daptomycindaptomycin
    16714-892DaptomycinDaptomycin
    16729-434DaptomycinDaptomycin
    16729-435DAPTOMYCINDaptomycin
    25021-174daptomycindaptomycin
    25021-179DaptomycinDaptomycin
    70594-034DaptomycinDaptomycin
    70594-053DaptomycinDaptomycin
    63323-871DaptomycinDaptomycin
    63323-371DaptomycinDaptomycin
    67457-813daptomycindaptomycin
    43598-413DaptomycinDaptomycin
    68001-376DaptomycinDaptomycin
    63323-585DaptomycinDaptomycin
    71839-107daptomycindaptomycin
    57884-3151DaptomycinDaptomycin
    69097-807DaptomycinDaptomycin
    72572-102DaptomycinDaptomycin
    72572-100DaptomycinDaptomycin
    45932-0039DaptomycinDaptomycin
    71288-018DAPTOMYCINDAPTOMYCIN
    76233-091DaptomycinDaptomycin
    31722-102DaptomycinDaptomycin

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