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 ID: 0378-4017_6d1a488f-2700-4061-840d-fcb2325ddd7e
• NDC: 0378-4017
• Product Type: Human Prescription Drug
• Proprietary Name: Desloratadine
• Generic Name: Desloratadine
• Dosage Form: Tablet, Film Coated
• Route of Administration: ORAL
• Marketing Start Date: 2012-07-02
• Marketing Category: ANDA / ANDA
• Application Number: ANDA078351
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: DESLORATADINE
• Active Ingredient Strength: 5 mg/1
• Pharm Classes: Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 0378-4017-01

100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-4017-01)

• Marketing Start Date: 2012-07-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-4017-05 [00378401705]

Desloratadine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078351
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-02
• Marketing End Date: 2019-06-30

NDC 0378-4017-01 [00378401701]

Desloratadine TABLET, FILM COATED

• Marketing Category: ANDA
• Application Number: ANDA078351
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2012-07-02
• Marketing End Date: 2019-06-30

Drug Details

Active Ingredients

Ingredient	Strength
DESLORATADINE	5 mg/1

OpenFDA Data

• SPL SET ID: 91ce2b02-8f8e-4929-a962-b8f88a40b70a
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • FVF865388R
• 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"

NDC	Brand Name	Generic Name
0378-4017	Desloratadine	desloratadine
42291-240	Desloratadine	Desloratadine
50090-3975	Desloratadine	Desloratadine
50090-4794	DESLORATADINE	DESLORATADINE
50268-218	Desloratadine	Desloratadine
51672-4159	Desloratadine	Desloratadine
55111-360	Desloratadine	Desloratadine
55111-551	Desloratadine	Desloratadine
62250-619	Desloratadine	Desloratadine
62756-523	Desloratadine	Desloratadine
63629-5270	Desloratadine	Desloratadine
68180-153	DESLORATADINE	DESLORATADINE
69543-107	Desloratadine	Desloratadine
71335-1000	DESLORATADINE	DESLORATADINE
0085-1264	Clarinex	Desloratadine
0085-1334	Clarinex	Desloratadine
21695-815	Clarinex	Desloratadine
50090-0765	Clarinex	Desloratadine
78206-119	Clarinex	Desloratadine
78206-188	Clarinex	Desloratadine