NDC 52083-685

ABANATUSS PED DROPS

Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride

ABANATUSS PED DROPS is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Kramer Novis. The primary component is Chlophedianol Hydrochloride; Dexchlorpheniramine Maleate; Pseudoephedrine Hydrochloride.

• Product ID: 52083-685_6a020469-111c-4c97-8479-7195161bb9ba
• NDC: 52083-685
• Product Type: Human Otc Drug
• Proprietary Name: ABANATUSS PED DROPS
• Generic Name: Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2015-08-05
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: KRAMER NOVIS
• Substance Name: CHLOPHEDIANOL HYDROCHLORIDE; DEXCHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
• Active Ingredient Strength: 6 mg/mL; mg/mL; mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 52083-685-01

1 BOTTLE, PLASTIC in 1 CARTON (52083-685-01) > 30 mL in 1 BOTTLE, PLASTIC

• Marketing Start Date: 2015-08-05
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52083-685-01 [52083068501]

ABANATUSS PED DROPS SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2015-08-05

Drug Details

Active Ingredients

Ingredient	Strength
CHLOPHEDIANOL HYDROCHLORIDE	6.25 mg/mL

OpenFDA Data

• SPL SET ID: 3ed68ac6-b7fd-4521-8f66-c686a2293d52
• Manufacturer:
  • KRAMER NOVIS
• UNII:
  • 6V9V2RYJ8N
  • B10YD955QW
  • 69QQ58998Y
• RxNorm Concept Unique ID - RxCUI:
  • 1369971
• UPC Code:
  • 0352083685019

NDC Crossover Matching brand name "ABANATUSS PED DROPS" or generic name "Chlophedianol Hydrochloride, Dexchlorpheniramine Maleate, Pseudoephedrine Hydrochloride"

NDC	Brand Name	Generic Name
52083-685	ABANATUSS PED DROPS	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE
52083-675	ABANATUSS PED	CHLOPHEDIANOL HYDROCHLORIDE, DEXCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE