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 ID: 0085-1322_14500ece-eea2-4589-8278-fbce510c7c7d
• NDC: 0085-1322
• Product Type: Human Prescription Drug
• Proprietary Name: CLARINEX-D 12 HOUR
• Generic Name: Desloratadine And Pseudoephedrine Sulfate
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2006-02-01
• Marketing Category: NDA / NDA
• Application Number: NDA021313
• Labeler Name: Merck Sharp & Dohme Corp.
• Substance Name: DESLORATADINE; PSEUDOEPHEDRINE SULFATE
• Active Ingredient Strength: 3 mg/1; mg/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC],Adrenergic alpha-Agonists [MoA],alpha-Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0085-1322-01

100 TABLET, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0085-1322-01)

• Marketing Start Date: 2006-02-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0085-1322-01 [00085132201]

CLARINEX-D 12 HOUR TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021313
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2006-02-01

Drug Details

Active Ingredients

Ingredient	Strength
DESLORATADINE	2.5 mg/1

OpenFDA Data

• SPL SET ID: 61a1562b-46c6-40ed-af02-305342e76e2f
• Manufacturer:
  • Merck Sharp & Dohme Corp.
• UNII:
  • FVF865388R
  • Y9DL7QPE6B
• 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"

NDC	Brand Name	Generic Name
0085-1322	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate
78206-120	CLARINEX-D 12 HOUR	desloratadine and pseudoephedrine sulfate