NDC 16477-101

Rondec-D

Chlophedianol Hydrochloride,pseudoephedrine Hydrochloride

Rondec-D is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Laser Pharmaceuticals, Llc. The primary component is Pseudoephedrine Hydrochloride; Chlophedianol Hydrochloride.

Product ID16477-101_7a7fdefb-fab8-0153-e053-2991aa0a183e
NDC16477-101
Product TypeHuman Otc Drug
Proprietary NameRondec-D
Generic NameChlophedianol Hydrochloride,pseudoephedrine Hydrochloride
Dosage FormLiquid
Route of AdministrationORAL
Marketing Start Date2017-11-21
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameLaser Pharmaceuticals, LLC
Substance NamePSEUDOEPHEDRINE HYDROCHLORIDE; CHLOPHEDIANOL HYDROCHLORIDE
Active Ingredient Strength30 mg/5mL; mg/5mL
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 16477-101-15

15 mL in 1 BOTTLE (16477-101-15)
Marketing Start Date2017-11-21
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 16477-101-15 [16477010115]

Rondec-D LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Marketing Start Date2017-11-21

NDC 16477-101-16 [16477010116]

Rondec-D LIQUID
Marketing CategoryOTC monograph final
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitML
Marketing Start Date2017-11-21

Drug Details

Active Ingredients

IngredientStrength
PSEUDOEPHEDRINE HYDROCHLORIDE30 mg/5mL

OpenFDA Data

SPL SET ID:5e851b0b-c815-e3a7-e053-2991aa0aabe6
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1369420

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