NDC 0168-0400

Calcipotriene

Calcipotriene

Calcipotriene is a Topical Solution in the Human Prescription Drug category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is Calcipotriene.

Product ID0168-0400_774dd89d-ce05-4c00-8770-e89c23865a26
NDC0168-0400
Product TypeHuman Prescription Drug
Proprietary NameCalcipotriene
Generic NameCalcipotriene
Dosage FormSolution
Route of AdministrationTOPICAL
Marketing Start Date2008-05-06
Marketing CategoryANDA / ANDA
Application NumberANDA078305
Labeler NameFougera Pharmaceuticals Inc.
Substance NameCALCIPOTRIENE
Active Ingredient Strength0 mg/mL
Pharm ClassesVitamin D [CS],Vitamin D Analog [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0168-0400-60

60 mL in 1 BOTTLE, PLASTIC (0168-0400-60)
Marketing Start Date2008-05-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0168-0400-60 [00168040060]

Calcipotriene SOLUTION
Marketing CategoryANDA
Application NumberANDA078305
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2008-05-06

Drug Details

Active Ingredients

IngredientStrength
CALCIPOTRIENE.05 mg/mL

OpenFDA Data

SPL SET ID:fff63bc7-6b92-4080-9a11-017124d95162
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 308865
  • UPC Code
  • 0301680400600
  • Pharmacological Class

    • Vitamin D [CS]
    • Vitamin D Analog [EPC]
    • Vitamin D [CS]
    • Vitamin D Analog [EPC]

    NDC Crossover Matching brand name "Calcipotriene" or generic name "Calcipotriene"

    NDCBrand NameGeneric Name
    0115-1475CalcipotrieneCalcipotriene
    0168-0400CalcipotrieneCalcipotriene
    0713-0318CalcipotrieneCalcipotriene
    0781-7117CalcipotrieneCalcipotriene
    16714-763calcipotrienecalcipotriene
    40032-043CalcipotrieneCalcipotriene
    50383-732CalcipotrieneCalcipotriene
    51407-605calcipotrienecalcipotriene
    51407-606CalcipotrieneCalcipotriene
    51672-4154CalcipotrieneCalcipotriene
    51862-512calcipotrienecalcipotriene
    66993-877CalcipotrieneCalcipotriene
    66993-878calcipotrienecalcipotriene
    68462-310CalcipotrieneCalcipotriene
    68462-501calcipotrienecalcipotriene
    51672-5278CalcitreneCalcipotriene
    50222-260DovonexCalcipotriene
    51862-376SORILUXcalcipotriene

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