NDC 0085-1322

CLARINEX-D 12 HOUR

Desloratadine And Pseudoephedrine Sulfate

CLARINEX-D 12 HOUR is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Merck Sharp & Dohme Corp.. The primary component is Desloratadine; Pseudoephedrine Sulfate.

Product ID0085-1322_14500ece-eea2-4589-8278-fbce510c7c7d
NDC0085-1322
Product TypeHuman Prescription Drug
Proprietary NameCLARINEX-D 12 HOUR
Generic NameDesloratadine And Pseudoephedrine Sulfate
Dosage FormTablet, Extended Release
Route of AdministrationORAL
Marketing Start Date2006-02-01
Marketing CategoryNDA / NDA
Application NumberNDA021313
Labeler NameMerck Sharp & Dohme Corp.
Substance NameDESLORATADINE; PSEUDOEPHEDRINE SULFATE
Active Ingredient Strength3 mg/1; mg/1
Pharm ClassesHistamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0085-1322-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0085-1322-01)
Marketing Start Date2006-02-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0085-1322-01 [00085132201]

CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE
Marketing CategoryNDA
Application NumberNDA021313
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2006-02-01

Drug Details

Active Ingredients

IngredientStrength
DESLORATADINE2.5 mg/1

OpenFDA Data

SPL SET ID:61a1562b-46c6-40ed-af02-305342e76e2f
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1112248
  • 1112250
  • Pharmacological Class

    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]
    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

    NDC Crossover Matching brand name "CLARINEX-D 12 HOUR" or generic name "Desloratadine And Pseudoephedrine Sulfate"

    NDCBrand NameGeneric Name
    0085-1322CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfate
    78206-120CLARINEX-D 12 HOURdesloratadine and pseudoephedrine sulfate

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