hycodan

Generic: hydrocodone bitartrate and homatropine methylbromide

Labeler: genus lifesciences inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name hycodan
Generic Name hydrocodone bitartrate and homatropine methylbromide
Labeler genus lifesciences inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

homatropine methylbromide 1.5 mg/5mL, hydrocodone bitartrate 5 mg/5mL

Manufacturer
Genus Lifesciences Inc.

Identifiers & Regulatory

Product NDC 64950-342
Product ID 64950-342_924196c1-61fe-4825-8ad2-41be1321f0d6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA005213
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2019-06-10

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950342
Hyphenated Format 64950-342

Supplemental Identifiers

RxCUI
992656 992660 992668 992671
UPC
0364950205039
UNII
NO70W886KK 68JRS2HC1C

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 hycodan (source: ndc)
Generic Name hydrocodone bitartrate and homatropine methylbromide (source: ndc)
Application Number NDA005213 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05)
  • 473 mL in 1 BOTTLE (64950-342-47)
source: ndc

Packages (2)

64950-342-45 40 CUP, UNIT-DOSE in 1 CASE (64950-342-45) / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05) 64950-342-47 473 mL in 1 BOTTLE (64950-342-47)

Ingredients (2)

homatropine methylbromide (1.5 mg/5mL) hydrocodone bitartrate (5 mg/5mL)

Linked Drug Pages (1)

Hycodan ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "924196c1-61fe-4825-8ad2-41be1321f0d6", "openfda": {"upc": ["0364950205039"], "unii": ["NO70W886KK", "68JRS2HC1C"], "rxcui": ["992656", "992660", "992668", "992671"], "spl_set_id": ["901d4115-f71a-4681-bd0e-c9b691151b78"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "40 CUP, UNIT-DOSE in 1 CASE (64950-342-45)  / 5 mL in 1 CUP, UNIT-DOSE (64950-342-05)", "package_ndc": "64950-342-45", "marketing_start_date": "20191216"}, {"sample": false, "description": "473 mL in 1 BOTTLE (64950-342-47)", "package_ndc": "64950-342-47", "marketing_start_date": "20190614"}], "brand_name": "Hycodan", "product_id": "64950-342_924196c1-61fe-4825-8ad2-41be1321f0d6", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64950-342", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hycodan", "active_ingredients": [{"name": "HOMATROPINE METHYLBROMIDE", "strength": "1.5 mg/5mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/5mL"}], "application_number": "NDA005213", "marketing_category": "NDA", "marketing_start_date": "20190610", "listing_expiration_date": "20261231"}