NDC 52584-816

CLINDAMYCIN

Clindamycin

CLINDAMYCIN is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by General Injectables And Vaccines, Inc.. The primary component is Clindamycin.

Product ID52584-816_247b2438-db4c-4d0e-a8e1-627ea3f02369
NDC52584-816
Product TypeHuman Prescription Drug
Proprietary NameCLINDAMYCIN
Generic NameClindamycin
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2018-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA204748
Labeler NameGeneral Injectables and Vaccines, Inc.
Substance NameCLINDAMYCIN
Active Ingredient Strength150 mg/mL
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 52584-816-00

1 VIAL, SINGLE-DOSE in 1 BAG (52584-816-00) > 6 mL in 1 VIAL, SINGLE-DOSE
Marketing Start Date2018-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 52584-816-00 [52584081600]

CLINDAMYCIN INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA204748
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-07-02
Marketing End Date2020-06-30

Drug Details

Active Ingredients

IngredientStrength
CLINDAMYCIN150 mg/mL

OpenFDA Data

SPL SET ID:654b38c3-bfed-47fa-827d-a92b3d93191c
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1737581

    • Pharmacological Class

    • Decreased Sebaceous Gland Activity [PE]
    • Lincosamide Antibacterial [EPC]
    • Lincosamides [CS]

    NDC Crossover Matching brand name "CLINDAMYCIN" or generic name "Clindamycin"

    NDCBrand NameGeneric Name
    0404-9838ClindamycinClindamycin Phosphate
    17478-120ClindamycinClindamycin Phosphate
    17478-121ClindamycinClindamycin Phosphate
    17478-122ClindamycinClindamycin Phosphate
    25021-115Clindamycinclindamycin phosphate
    47781-459Clindamycinclindamycin phosphate
    47781-460Clindamycinclindamycin phosphate
    47781-461Clindamycinclindamycin phosphate
    47781-462Clindamycinclindamycin phosphate
    47781-463Clindamycinclindamycin phosphate
    47781-464Clindamycinclindamycin phosphate
    47781-465Clindamycinclindamycin phosphate
    51662-1437CLINDAMYCINCLINDAMYCIN
    71872-7088ClindamycinClindamycin
    71872-7123ClindamycinClindamycin
    71872-7089ClindamycinClindamycin
    52584-814CLINDAMYCINCLINDAMYCIN
    52584-815CLINDAMYCINCLINDAMYCIN
    52584-816CLINDAMYCINCLINDAMYCIN
    55154-2828ClindamycinClindamycin
    63323-282ClindamycinClindamycin
    67457-814ClindamycinClindamycin
    67457-815ClindamycinClindamycin
    67457-816ClindamycinClindamycin
    71872-7168ClindamycinClindamycin
    52584-090ClindamycinClindamycin
    67457-817ClindamycinClindamycin
    16781-462ClindagelCLINDAMYCIN
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