NDC 17856-0235

Hydrocodone Polistirex and Chlorpheniramine Polisitrex

Hydrocodone Polistirex And Chlorpheniramine Polisitrex

Hydrocodone Polistirex and Chlorpheniramine Polisitrex is a Oral Suspension, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Atlantic Biologicals Corps. The primary component is Hydrocodone Bitartrate; Chlorpheniramine Maleate.

Product ID17856-0235_f75c6ba1-6695-4bcb-88ec-63efd2acdf92
NDC17856-0235
Product TypeHuman Prescription Drug
Proprietary NameHydrocodone Polistirex and Chlorpheniramine Polisitrex
Generic NameHydrocodone Polistirex And Chlorpheniramine Polisitrex
Dosage FormSuspension, Extended Release
Route of AdministrationORAL
Marketing Start Date2012-08-16
Marketing CategoryANDA / ANDA
Application NumberANDA091632
Labeler NameAtlantic Biologicals Corps
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 FlagE
Listing Certified Through2018-12-31

Packaging

NDC 17856-0235-1

5 mL in 1 CUP, UNIT-DOSE (17856-0235-1)
Marketing Start Date2012-08-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 17856-0235-1 [17856023501]

Hydrocodone Polistirex and Chlorpheniramine Polisitrex SUSPENSION, EXTENDED RELEASE
Marketing CategoryANDA
Application NumberANDA091632
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-08-16
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
HYDROCODONE BITARTRATE10 mg/5mL

OpenFDA Data

SPL SET ID:566d28f3-4b16-4881-9347-2175e5060ffb
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]

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