hydrocodone polistirex and chlorpheniramine polistirex extended-release

Generic: hydrocodone polistirex and chlorpheniramine polistirex

Labeler: bryant ranch prepack
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone polistirex and chlorpheniramine polistirex extended-release
Generic Name hydrocodone polistirex and chlorpheniramine polistirex
Labeler bryant ranch prepack
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

chlorpheniramine maleate 8 mg/5mL, hydrocodone bitartrate 10 mg/5mL

Manufacturer
Bryant Ranch Prepack

Identifiers & Regulatory

Product NDC 72162-1283
Product ID 72162-1283_bbff7b05-68a1-4124-9dec-74f8f6cfd058
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091632
DEA Schedule cii
Marketing Start 2015-03-06
Marketing End 2026-09-30

Pharmacologic Class

Classes
histamine h1 receptor antagonists [moa] histamine-1 receptor antagonist [epc] opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 721621283
Hyphenated Format 72162-1283

Supplemental Identifiers

RxCUI
1087459
UNII
V1Q0O9OJ9Z NO70W886KK

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name hydrocodone polistirex and chlorpheniramine polistirex extended-release (source: ndc)
Generic Name hydrocodone polistirex and chlorpheniramine polistirex (source: ndc)
Application Number ANDA091632 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 8 mg/5mL
  • 10 mg/5mL
source: ndc
Packaging
  • 115 mL in 1 BOTTLE (72162-1283-2)
  • 473 mL in 1 BOTTLE (72162-1283-4)
source: ndc

Packages (2)

72162-1283-2 115 mL in 1 BOTTLE (72162-1283-2) 72162-1283-4 473 mL in 1 BOTTLE (72162-1283-4)

Ingredients (2)

chlorpheniramine maleate (8 mg/5mL) hydrocodone bitartrate (10 mg/5mL)

Linked Drug Pages (1)

Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "bbff7b05-68a1-4124-9dec-74f8f6cfd058", "openfda": {"unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "rxcui": ["1087459"], "spl_set_id": ["03d40087-b413-4f19-af4a-e0f60b0ff542"], "manufacturer_name": ["Bryant Ranch Prepack"]}, "finished": true, "packaging": [{"sample": false, "description": "115 mL in 1 BOTTLE (72162-1283-2)", "package_ndc": "72162-1283-2", "marketing_end_date": "20260930", "marketing_start_date": "20230421"}, {"sample": false, "description": "473 mL in 1 BOTTLE (72162-1283-4)", "package_ndc": "72162-1283-4", "marketing_end_date": "20260930", "marketing_start_date": "20230421"}], "brand_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release", "product_id": "72162-1283_bbff7b05-68a1-4124-9dec-74f8f6cfd058", "dosage_form": "SUSPENSION, EXTENDED RELEASE", "pharm_class": ["Histamine H1 Receptor Antagonists [MoA]", "Histamine-1 Receptor Antagonist [EPC]", "Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "72162-1283", "dea_schedule": "CII", "generic_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex", "labeler_name": "Bryant Ranch Prepack", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Polistirex and Chlorpheniramine Polistirex", "brand_name_suffix": "extended-release", "active_ingredients": [{"name": "CHLORPHENIRAMINE MALEATE", "strength": "8 mg/5mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "10 mg/5mL"}], "application_number": "ANDA091632", "marketing_category": "ANDA", "marketing_end_date": "20260930", "marketing_start_date": "20150306"}