NDC 17856-0087

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 Atlantic Biologicals Corp.. The primary component is Chlorpheniramine Maleate; Hydrocodone Bitartrate.

Product ID17856-0087_006b0771-3a21-4603-bf6b-dcd19abb29ca
NDC17856-0087
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 NameATLANTIC BIOLOGICALS CORP.
Substance NameCHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
Active Ingredient Strength8 mg/5mL; mg/5mL
Pharm ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Opioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII
NDC Exclude FlagN
Listing Certified Through2024-12-31

Packaging

NDC 17856-0087-2

1 BOX, UNIT-DOSE in 1 CUP, UNIT-DOSE (17856-0087-2) > 5 BOX, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-3) > 72 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0087-1) > 5 mL in 1 CUP, UNIT-DOSE
Marketing Start Date2023-01-10
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0087-1 [17856008701]

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091632
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-09-27

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/5mL

OpenFDA Data

SPL SET ID:9445fb20-9601-44e8-ac08-b27e1e214755
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 1087459
  • Pharmacological Class

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

    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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