NDC 0378-4017

Desloratadine

Desloratadine

Desloratadine is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Desloratadine.

Product ID0378-4017_6d1a488f-2700-4061-840d-fcb2325ddd7e
NDC0378-4017
Product TypeHuman Prescription Drug
Proprietary NameDesloratadine
Generic NameDesloratadine
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2012-07-02
Marketing CategoryANDA / ANDA
Application NumberANDA078351
Labeler NameMylan Pharmaceuticals Inc.
Substance NameDESLORATADINE
Active Ingredient Strength5 mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0378-4017-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4017-01)
Marketing Start Date2012-07-02
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-4017-05 [00378401705]

Desloratadine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078351
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02
Marketing End Date2019-06-30

NDC 0378-4017-01 [00378401701]

Desloratadine TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA078351
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2012-07-02
Marketing End Date2019-06-30

Drug Details

Active Ingredients

IngredientStrength
DESLORATADINE5 mg/1

OpenFDA Data

SPL SET ID:91ce2b02-8f8e-4929-a962-b8f88a40b70a
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 349420
  • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]

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

    NDCBrand NameGeneric Name
    0378-4017Desloratadinedesloratadine
    42291-240DesloratadineDesloratadine
    50090-3975DesloratadineDesloratadine
    50090-4794DESLORATADINEDESLORATADINE
    50268-218DesloratadineDesloratadine
    51672-4159DesloratadineDesloratadine
    55111-360DesloratadineDesloratadine
    55111-551DesloratadineDesloratadine
    62250-619DesloratadineDesloratadine
    62756-523DesloratadineDesloratadine
    63629-5270DesloratadineDesloratadine
    68180-153DESLORATADINEDESLORATADINE
    69543-107DesloratadineDesloratadine
    71335-1000DESLORATADINEDESLORATADINE
    0085-1264ClarinexDesloratadine
    0085-1334ClarinexDesloratadine
    21695-815ClarinexDesloratadine
    50090-0765ClarinexDesloratadine
    78206-119ClarinexDesloratadine
    78206-188ClarinexDesloratadine

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