NDC 27808-086

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release

Hydrocodone Polistirex And Chlorpheniramine Polistirex

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Tris Pharma Inc. The primary component is Hydrocodone Bitartrate; Chlorpheniramine Maleate.

Product ID27808-086_68aacf08-9d3b-41ae-a72c-8129ef090991
NDC27808-086
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Polistirex and Chlorpheniramine Polistirex extended-release
Generic NameHydrocodone Polistirex And Chlorpheniramine Polistirex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2015-03-06
Marketing CategoryANDA / ANDA
Application NumberANDA091632
Labeler NameTris Pharma Inc
Substance NameHYDROCODONE BITARTRATE; CHLORPHENIRAMINE MALEATE
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 Through2022-12-31

Packaging

NDC 27808-086-01

1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) > 115 mL in 1 BOTTLE, UNIT-DOSE
Marketing Start Date2015-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 27808-086-03 [27808008603]

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091632
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-10-01

NDC 27808-086-01 [27808008601]

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091632
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-06

NDC 27808-086-02 [27808008602]

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091632
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2015-03-06

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/5mL

OpenFDA Data

SPL SET ID:25f400d9-1d6e-4d38-8f0d-98d471eba73b
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087459
  • UPC Code
  • 0327808086020
  • 0327808086013
  • Pharmacological Class

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

    Medicade Reported Pricing

    27808008602 HYDROCODONE-CHLORPHEN ER SUSP

    Pricing Unit: ML | Drug Type:

    27808008601 HYDROCODONE-CHLORPHEN ER SUSP

    Pricing Unit: ML | Drug Type:

    NDC Crossover Matching brand name "Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release" 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

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