NDC 62542-301

Hydrocodone Polistirex and Chlorpheniramine Polistirex

Hydrocodone Polistirex And Chlorpheniramine Polistirex

Hydrocodone Polistirex and Chlorpheniramine Polistirex is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Neos Therapeutics Lp. The primary component is Hydrocodone; Chlorpheniramine.

Product ID62542-301_22afeab4-8c3b-4ef9-9947-f47b5ced30d1
NDC62542-301
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Polistirex and Chlorpheniramine Polistirex
Generic NameHydrocodone Polistirex And Chlorpheniramine Polistirex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2014-10-23
Marketing CategoryANDA / ANDA
Application NumberANDA091671
Labeler NameNeos Therapeutics LP
Substance NameHYDROCODONE; CHLORPHENIRAMINE
Active Ingredient Strength10 mg/5mL; mg/5mL
Pharm ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 62542-301-03

70 mL in 1 BOTTLE, GLASS (62542-301-03)
Marketing Start Date2019-11-05
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 62542-301-04 [62542030104]

Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-23
Inactivation Date2020-01-31

NDC 62542-301-17 [62542030117]

Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-23
Inactivation Date2020-01-31

NDC 62542-301-16 [62542030116]

Hydrocodone Polistirex and Chlorpheniramine Polistirex SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091671
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-10-23
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE10 mg/5mL

OpenFDA Data

SPL SET ID:0a442026-486d-105a-e054-00144ff88e88
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087459
  • UPC Code
  • 0362542301046
  • Pharmacological Class

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

    Medicade Reported Pricing

    62542030117 HYDROCODONE-CHLORPHEN ER SUSP

    Pricing Unit: ML | Drug Type:

    62542030116 HYDROCODONE-CHLORPHEN ER SUSP

    Pricing Unit: ML | Drug Type:

    62542030104 HYDROCODONE-CHLORPHEN ER SUSP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Hydrocodone Polistirex and Chlorpheniramine Polistirex" or generic name "Hydrocodone Polistirex And Chlorpheniramine Polistirex"

    NDCBrand NameGeneric Name
    17856-0087Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    17856-0301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    27808-086Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    62542-301Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    63629-2303Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    63629-2304Hydrocodone Polistirex and Chlorpheniramine PolistirexHydrocodone Polistirex and Chlorpheniramine Polistirex
    62175-490Hydrocodone Polistirex and Chlorpheniramine Polistirex Pennkinetichydrocodone polistirex and chlorpheniramine polistirex
    0187-0108TussiCapshydrocodone polistirex and chlorpheniramine polistirex
    53014-548Tussionex Pennkinetichydrocodone polistirex and chlorpheniramine polistirex

    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.