NDC 15370-110

PediaVent

Dexbrompheniramine Maleate

PediaVent is a Oral Syrup in the Human Otc Drug category. It is labeled and distributed by Carwin Pharmaceutical Associates, Llc. The primary component is Dexbrompheniramine Maleate.

• Product ID: 15370-110_b1c39371-c657-41d7-9110-4af33245037a
• NDC: 15370-110
• Product Type: Human Otc Drug
• Proprietary Name: PediaVent
• Generic Name: Dexbrompheniramine Maleate
• Dosage Form: Syrup
• Route of Administration: ORAL
• Marketing Start Date: 2014-08-04
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: CarWin Pharmaceutical Associates, LLC
• Substance Name: DEXBROMPHENIRAMINE MALEATE
• Active Ingredient Strength: 2 mg/5mL
• NDC Exclude Flag: E
• Listing Certified Through: 2018-12-31

Packaging

NDC 15370-110-04

118 mL in 1 BOTTLE (15370-110-04)

• Marketing Start Date: 2014-08-04
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 15370-110-04 [15370011004]

PediaVent SYRUP

• Marketing Category: OTC MONOGRAPH FINAL
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2014-08-04
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
DEXBROMPHENIRAMINE MALEATE	2 mg/5mL

OpenFDA Data

• SPL SET ID: 16687961-4660-4233-9a90-5637fae1c4da
• Manufacturer:
  • CarWin Pharmaceutical Associates, LLC
• UNII:
  • BPA9UT29BS
• RxNorm Concept Unique ID - RxCUI:
  • 1545309
• UPC Code:
  • 0315370110045

NDC Crossover Matching brand name "PediaVent" or generic name "Dexbrompheniramine Maleate"

NDC	Brand Name	Generic Name
15370-110	PediaVent	DEXBROMPHENIRAMINE MALEATE
15370-112	PediaVent	DEXBROMPHENIRAMINE MALEATE
50991-783	ALA-HIST IR	Dexbrompheniramine Maleate