NDC 45802-042

Clindesse

Clindamycin Phosphate

Clindesse is a Vaginal Cream in the Human Prescription Drug category. It is labeled and distributed by Padagis Israel Pharmaceuticals Ltd. The primary component is Clindamycin Phosphate.

Product ID45802-042_0640a4a5-8ff8-4fd5-a25c-9ae321af586e
NDC45802-042
Product TypeHuman Prescription Drug
Proprietary NameClindesse
Generic NameClindamycin Phosphate
Dosage FormCream
Route of AdministrationVAGINAL
Marketing Start Date2015-07-03
Marketing CategoryNDA / NDA
Application NumberNDA050793
Labeler NamePadagis Israel Pharmaceuticals Ltd
Substance NameCLINDAMYCIN PHOSPHATE
Active Ingredient Strength100 mg/5g
Pharm ClassesDecreased Sebaceous Gland Activity [PE],Lincosamide Antibacterial [EPC],Lincosamides [CS],Neuromuscular Blockade [PE]
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 45802-042-01

1 APPLICATOR in 1 CARTON (45802-042-01) > 5 g in 1 APPLICATOR
Marketing Start Date2015-07-03
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 45802-042-01 [45802004201]

Clindesse CREAM
Marketing CategoryNDA
Application NumberNDA050793
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitGM
Marketing Start Date2015-07-03

NDC 45802-042-02 [45802004202]

Clindesse CREAM
Marketing CategoryNDA
Application NumberNDA050793
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-07-03

Drug Details

Active Ingredients

IngredientStrength
CLINDAMYCIN PHOSPHATE100 mg/5g

OpenFDA Data

SPL SET ID:fe8bb204-f173-44fe-803b-b08f2ec5aa31
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 309337
  • 602427
  • Pharmacological Class

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

    Medicade Reported Pricing

    45802042578 FEXOFENADINE HCL 60 MG TABLET

    Pricing Unit: EA | Drug Type:

    45802042337 DESONIDE 0.05% OINTMENT

    Pricing Unit: GM | Drug Type:

    45802042335 DESONIDE 0.05% OINTMENT

    Pricing Unit: GM | Drug Type:

    45802042237 DESONIDE 0.05% CREAM

    Pricing Unit: GM | Drug Type:

    45802042235 DESONIDE 0.05% CREAM

    Pricing Unit: GM | Drug Type:

    45802004201 CLINDESSE 2% VAGINAL CREAM

    Pricing Unit: GM | Drug Type:

    NDC Crossover Matching brand name "Clindesse" or generic name "Clindamycin Phosphate"

    NDCBrand NameGeneric Name
    45802-042ClindesseClindesse
    64011-124ClindesseClindesse
    0009-0302Cleocin Phosphateclindamycin phosphate
    0009-0602Cleocin Phosphateclindamycin phosphate
    0009-0728Cleocin Phosphateclindamycin phosphate
    0009-0775Cleocin Phosphateclindamycin phosphate
    0009-0870Cleocin Phosphateclindamycin phosphate

    Trademark Results [Clindesse]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    CLINDESSE
    CLINDESSE
    78499863 3184560 Live/Registered
    PERRIGO PHARMA INTERNATIONAL DESIGNATEDACTIVITY COMPANY
    2004-10-14

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