NDC 59741-267

HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE

Hydrocodone Bitartrate Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride Oral

HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE is a Oral Solution in the Human Prescription Drug category. It is labeled and distributed by Bio-pharm, Inc.. The primary component is Hydrocodone Bit.

Product ID59741-267_7f966596-2439-2535-e053-2991aa0ac75e
NDC59741-267
Product TypeHuman Prescription Drug
Proprietary NameHYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
Generic NameHydrocodone Bitartrate Chlorpheniramine Maleate And Pseudoephedrine Hydrochloride Oral
Dosage FormSolution
Route of AdministrationORAL
Marketing Start Date2017-05-16
Marketing CategoryANDA / ANDA
Application NumberANDA206660
Labeler NameBio-Pharm, Inc.
Substance NameHYDROCODONE BIT
Active Ingredient Strength5 mg/5mL; mg/5mL;
Pharm ClassesOpioid Agonist
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 59741-267-16

480 mL in 1 BOTTLE (59741-267-16)
Marketing Start Date2017-05-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 59741-267-16 [59741026716]

HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA206660
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-16
Marketing End Date2017-05-16

NDC 59741-267-17 [59741026717]

HYDROCODONE BITARTRATE CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE SOLUTION
Marketing CategoryANDA
Application NumberANDA206660
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-05-16
Marketing End Date2017-05-16

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE5 mg/5mL

OpenFDA Data

SPL SET ID:fff53aac-2191-464d-a83e-fd9e582e0298
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1112220
  • UPC Code
  • 0359741267174
  • Pharmacological Class

    • Opioid Agonist [EPC]
    • Opioid Agonists [MoA]
    • Histamine H1 Receptor Antagonists [MoA]
    • Histamine-1 Receptor Antagonist [EPC]
    • Adrenergic alpha-Agonists [MoA]
    • alpha-Adrenergic Agonist [EPC]

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