NDC 64543-600

POLMON

Dexchlorpheniramine Maleate

POLMON is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Capellon Pharmaceuticals, Llc. The primary component is Dexchlorpheniramine Maleate.

• Product ID: 64543-600_712516a6-8c71-8f10-e053-2995a90a5db1
• NDC: 64543-600
• Product Type: Human Prescription Drug
• Proprietary Name: POLMON
• Generic Name: Dexchlorpheniramine Maleate
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-07-16
• Marketing Category: ANDA / ANDA
• Application Number: ANDA202520
• Labeler Name: Capellon Pharmaceuticals, LLC
• Substance Name: DEXCHLORPHENIRAMINE MALEATE
• Active Ingredient Strength: 2 mg/5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 64543-600-04

118 mL in 1 BOTTLE (64543-600-04)

• Marketing Start Date: 2018-07-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 64543-600-16 [64543060016]

POLMON SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202520
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-16

NDC 64543-600-04 [64543060004]

POLMON SOLUTION

• Marketing Category: ANDA
• Application Number: ANDA202520
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2018-07-16

Drug Details

Active Ingredients

Ingredient	Strength
DEXCHLORPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 2e5b9bfc-f58b-49f0-84f2-4efc10061ae3
• Manufacturer:
  • Capellon Pharmaceuticals, LLC
• UNII:
  • B10YD955QW
• RxNorm Concept Unique ID - RxCUI:
  • 702220

NDC Crossover Matching brand name "POLMON" or generic name "Dexchlorpheniramine Maleate"

NDC	Brand Name	Generic Name
64543-600	POLMON	Dexchlorpheniramine Maleate
69067-102	Dexchlorpheniramine Maleate	Dexchlorpheniramine Maleate
15370-150	RYCLORA	Dexchlorpheniramine Maleate