NDC 67787-515

clindamycin palmitate hydrochloride (pediatric)

Clindamycin Palmitate Hydrochloride

clindamycin palmitate hydrochloride (pediatric) is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Invagen Pharmaceuticals, Inc.. The primary component is Clindamycin Palmitate Hydrochloride.

Product ID67787-515_5344c7ba-77cc-458f-8766-4dcf25591b57
NDC67787-515
Product TypeHuman Prescription Drug
Proprietary Nameclindamycin palmitate hydrochloride (pediatric)
Generic NameClindamycin Palmitate Hydrochloride
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2019-09-11
Marketing CategoryANDA / ANDA
Application NumberANDA206958
Labeler NameInvaGen Pharmaceuticals, Inc.
Substance NameCLINDAMYCIN PALMITATE HYDROCHLORIDE
Active Ingredient Strength75 mg/5mL
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 67787-515-71

1 BOTTLE in 1 CARTON (67787-515-71) > 100 mL in 1 BOTTLE
Marketing Start Date2019-09-11
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67787-515-71 [67787051571]

clindamycin palmitate hydrochloride (pediatric) SOLUTION
Marketing CategoryANDA
Application NumberANDA206958
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-11

Drug Details

Active Ingredients

IngredientStrength
CLINDAMYCIN PALMITATE HYDROCHLORIDE75 mg/5mL

OpenFDA Data

SPL SET ID:d8cefc80-e0c7-4b18-83d6-5edd4f6f2af4
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 (pediatric)" or generic name "Clindamycin Palmitate Hydrochloride"

    NDCBrand NameGeneric Name
    16714-483Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)
    65862-596Clindamycin Palmitate Hydrochloride (Pediatric)Clindamycin Palmitate Hydrochloride (Pediatric)
    67787-515clindamycin palmitate hydrochloride (pediatric)clindamycin palmitate hydrochloride (pediatric)
    0009-0760Cleocin Pediatricclindamycin palmitate hydrochloride
    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
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