NDC 0009-0395

Cleocin Hydrochloride

Clindamycin Hydrochloride

Cleocin Hydrochloride is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Pharmacia And Upjohn Company Llc. The primary component is Clindamycin Hydrochloride.

Product ID0009-0395_3c9c02e0-e5f1-4353-978e-cefbfa189abd
NDC0009-0395
Product TypeHuman Prescription Drug
Proprietary NameCleocin Hydrochloride
Generic NameClindamycin Hydrochloride
Dosage FormCapsule
Route of AdministrationORAL
Marketing Start Date1970-05-22
Marketing CategoryNDA / NDA
Application NumberNDA050162
Labeler NamePharmacia and Upjohn Company LLC
Substance NameCLINDAMYCIN HYDROCHLORIDE
Active Ingredient Strength300 mg/1
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0009-0395-14

100 CAPSULE in 1 BOTTLE (0009-0395-14)
Marketing Start Date1970-05-22
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0009-0395-02 [00009039502]

Cleocin Hydrochloride CAPSULE
Marketing CategoryNDA
Application NumberNDA050162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1970-05-22
Marketing End Date2014-12-31

NDC 0009-0395-14 [00009039514]

Cleocin Hydrochloride CAPSULE
Marketing CategoryNDA
Application NumberNDA050162
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date1970-05-22

NDC 0009-0395-13 [00009039513]

Cleocin Hydrochloride CAPSULE
Marketing CategoryNDA
Application NumberNDA050162
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1970-05-22
Marketing End Date2011-06-28

Drug Details

Active Ingredients

IngredientStrength
CLINDAMYCIN HYDROCHLORIDE300 mg/1

OpenFDA Data

SPL SET ID:df9a2a41-b132-4f43-8940-b2d773b1369a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 284215
  • 197518
  • 748746
  • 748750
  • 309329
  • 748748

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0009-0225Cleocin Hydrochlorideclindamycin hydrochloride
    0009-0331Cleocin Hydrochlorideclindamycin hydrochloride
    0009-0395Cleocin Hydrochlorideclindamycin hydrochloride
    67296-1798Cleocin HydrochlorideCleocin Hydrochloride
    0179-0146Clindamycin HydrochlorideClindamycin Hydrochloride
    0179-0167Clindamycin HydrochlorideClindamycin Hydrochloride
    0440-7300Clindamycin hydrochlorideClindamycin hydrochloride
    0527-1381Clindamycin HydrochlorideClindamycin Hydrochloride
    0527-1382Clindamycin HydrochlorideClindamycin Hydrochloride
    0527-1383Clindamycin HydrochlorideClindamycin Hydrochloride
    0591-2932Clindamycin HydrochlorideClindamycin Hydrochloride
    © 2025 FDA.report
    This site is not affiliated with or endorsed by the FDA.