NDC 0536-1068

Robafen Cough Non-Drowsy Formula

Dextromethorphan Hbr

Robafen Cough Non-Drowsy Formula is a Oral Capsule, Liquid Filled in the Human Otc Drug category. It is labeled and distributed by Rugby Laboratories. The primary component is Dextromethorphan Hydrobromide.

Product ID0536-1068_41f3d525-5f6a-4b3b-bf16-d5fb8efe9625
NDC0536-1068
Product TypeHuman Otc Drug
Proprietary NameRobafen Cough Non-Drowsy Formula
Generic NameDextromethorphan Hbr
Dosage FormCapsule, Liquid Filled
Route of AdministrationORAL
Marketing Start Date2015-03-01
Marketing CategoryOTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
Application Numberpart341
Labeler NameRugby Laboratories
Substance NameDEXTROMETHORPHAN HYDROBROMIDE
Active Ingredient Strength15 mg/1
Pharm ClassesSigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0536-1068-34

1 BOTTLE in 1 PACKAGE (0536-1068-34) > 20 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Start Date2015-03-01
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0536-1068-34 [00536106834]

Robafen Cough Non-Drowsy Formula CAPSULE, LIQUID FILLED
Marketing CategoryOTC MONOGRAPH FINAL
Application Numberpart341
Product TypeHUMAN OTC DRUG
Billing UnitEA
Marketing Start Date2015-03-01

Drug Details

Active Ingredients

IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1

OpenFDA Data

SPL SET ID:206fff2b-1b9d-4b7f-bcef-b055825d4fe7
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1111766
  • 1090487
  • UPC Code
  • 0305361068349
  • NDC Crossover Matching brand name "Robafen Cough Non-Drowsy Formula" or generic name "Dextromethorphan Hbr"

    NDCBrand NameGeneric Name
    21130-383Adult Cough Relief DMDextromethorphan HBr
    0363-0500CoughDextromethorphan HBr
    15127-661Cough ControlDextromethorphan HBr
    0363-8990Cough ReliefDEXTROMETHORPHAN HBr
    15127-309Cough ReliefDextromethorphan HBr
    24385-262Cough ReliefDextromethorphan HBr
    24385-263Cough ReliefDextromethorphan HBr
    33992-0666Cough ReliefDextromethorphan HBr
    36800-454Cough ReliefDextromethorphan HBr
    36800-509Cough ReliefDextromethorphan HBr
    0536-1323Dextromethorphan HBrDextromethorphan HBr
    0536-1334Dextromethorphan HBr 15 mg Liquid GelsDextromethorphan HBr
    0395-9126Father Johns MedicineDextromethorphan HBr
    0536-1068Robafen CoughDextromethorphan HBr
    0031-8741ROBITUSSIN LINGERING COLD LONG-ACTING COUGHGELSdextromethorphan HBr
    21130-635Signature Care Daytime CoughDextromethorphan HBr
    0363-6610Wal-TussinDextromethorphan HBr

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