hydrocodone polistirex and chlorpheniramine polistirex extended-release

Generic: hydrocodone polistirex and chlorpheniramine polistirex

Labeler: cranbury pharmaceuticals, llc
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 cranbury pharmaceuticals, llc
Dosage Form SUSPENSION, EXTENDED RELEASE
Routes
ORAL
Active Ingredients

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

Manufacturer
Cranbury Pharmaceuticals, LLC

Identifiers & Regulatory

Product NDC 27808-086
Product ID 27808-086_b3ac95d4-bef9-4e32-9822-73b9534c9869
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091632
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2015-03-06

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 27808086
Hyphenated Format 27808-086

Supplemental Identifiers

RxCUI
1087459
UPC
0327808086013
UNII
V1Q0O9OJ9Z NO70W886KK

Packaging Origin

Original Packager
true

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
  • 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) / 115 mL in 1 BOTTLE, UNIT-DOSE
  • 473 mL in 1 BOTTLE (27808-086-02)
source: ndc

Packages (2)

27808-086-01 1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01) / 115 mL in 1 BOTTLE, UNIT-DOSE 27808-086-02 473 mL in 1 BOTTLE (27808-086-02)

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": "b3ac95d4-bef9-4e32-9822-73b9534c9869", "openfda": {"upc": ["0327808086013"], "unii": ["V1Q0O9OJ9Z", "NO70W886KK"], "rxcui": ["1087459"], "spl_set_id": ["25f400d9-1d6e-4d38-8f0d-98d471eba73b"], "manufacturer_name": ["Cranbury Pharmaceuticals, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, UNIT-DOSE in 1 CARTON (27808-086-01)  / 115 mL in 1 BOTTLE, UNIT-DOSE", "package_ndc": "27808-086-01", "marketing_start_date": "20150306"}, {"sample": false, "description": "473 mL in 1 BOTTLE (27808-086-02)", "package_ndc": "27808-086-02", "marketing_start_date": "20150306"}], "brand_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex extended-release", "product_id": "27808-086_b3ac95d4-bef9-4e32-9822-73b9534c9869", "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": "27808-086", "dea_schedule": "CII", "generic_name": "Hydrocodone Polistirex and Chlorpheniramine Polistirex", "labeler_name": "Cranbury Pharmaceuticals, LLC", "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_start_date": "20150306", "listing_expiration_date": "20271231"}