NDC 10135-569

Clindamycin Palmitate Hydrochloride

Clindamycin Palmitate Hydrochloride

Clindamycin Palmitate Hydrochloride is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Marlex Pharmaceuticals Inc. The primary component is Clindamycin Palmitate Hydrochloride.

Product ID10135-569_252ab443-71b1-442b-b990-73794cec49f4
NDC10135-569
Product TypeHuman Prescription Drug
Proprietary NameClindamycin Palmitate Hydrochloride
Generic NameClindamycin Palmitate Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2015-08-01
Marketing CategoryANDA / ANDA
Application NumberANDA203513
Labeler NameMarlex Pharmaceuticals Inc
Substance NameCLINDAMYCIN PALMITATE HYDROCHLORIDE
Active Ingredient Strength75 mg/5mL
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC Exclude FlagE
Listing Certified Through2017-12-31

Packaging

NDC 10135-569-19

1 BOTTLE in 1 BOX (10135-569-19) > 100 mL in 1 BOTTLE
Marketing Start Date2015-08-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 10135-569-19 [10135056919]

Clindamycin Palmitate Hydrochloride SOLUTION
Marketing CategoryANDA
Application NumberANDA203513
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-08-01

Drug Details

Active Ingredients

IngredientStrength
CLINDAMYCIN PALMITATE HYDROCHLORIDE75 mg/5mL

OpenFDA Data

SPL SET ID:6ba35f86-b421-4add-9769-f02b4e4c600f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 562266

    • Pharmacological Class

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

    NDC Crossover Matching brand name "Clindamycin Palmitate Hydrochloride" or generic name "Clindamycin Palmitate Hydrochloride"

    NDCBrand NameGeneric Name
    0374-5070CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDE
    0574-0129Clindamycin Palmitate HydrochlorideClindamycin Palmitate Hydrochloride
    10135-569Clindamycin Palmitate HydrochlorideClindamycin Palmitate Hydrochloride
    23155-603clindamycin palmitate hydrochlorideclindamycin palmitate hydrochloride
    59762-0016clindamycin palmitate hydrochlorideclindamycin palmitate hydrochloride
    63629-2391CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDE
    63629-2523Clindamycin Palmitate HydrochlorideClindamycin Palmitate Hydrochloride
    64980-511CLINDAMYCIN PALMITATE HYDROCHLORIDECLINDAMYCIN PALMITATE HYDROCHLORIDE
    65162-468Clindamycin Palmitate HydrochlorideClindamycin Palmitate Hydrochloride
    67787-515clindamycin palmitate hydrochlorideclindamycin palmitate hydrochloride
    0009-0760Cleocin Pediatricclindamycin palmitate hydrochloride
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