hydrocodone bitartrate and homatropine methylbromide

Generic: hydrocodone bitartrate and homatropine methylbromide

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

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and homatropine methylbromide
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 64950-371
Product ID 64950-371_36258c4f-6e18-4fe0-8c35-e77e4d215d94
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA005213
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2022-08-10

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 64950371
Hyphenated Format 64950-371

Supplemental Identifiers

RxCUI
992656 992668
UPC
0364950206036
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 hydrocodone bitartrate and homatropine methylbromide (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
  • 473 mL in 1 BOTTLE (64950-371-47)
source: ndc

Packages (1)

64950-371-47 473 mL in 1 BOTTLE (64950-371-47)

Ingredients (2)

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

Linked Drug Pages (1)

Hydrocodone Bitartrate and Homatropine Methylbromide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "36258c4f-6e18-4fe0-8c35-e77e4d215d94", "openfda": {"upc": ["0364950206036"], "unii": ["NO70W886KK", "68JRS2HC1C"], "rxcui": ["992656", "992668"], "spl_set_id": ["320ff639-9854-407b-9bbd-a035c4f173e1"], "manufacturer_name": ["Genus Lifesciences Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (64950-371-47)", "package_ndc": "64950-371-47", "marketing_start_date": "20220810"}], "brand_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "product_id": "64950-371_36258c4f-6e18-4fe0-8c35-e77e4d215d94", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "64950-371", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "labeler_name": "Genus Lifesciences Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Homatropine Methylbromide", "active_ingredients": [{"name": "HOMATROPINE METHYLBROMIDE", "strength": "1.5 mg/5mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/5mL"}], "application_number": "NDA005213", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20220810", "listing_expiration_date": "20261231"}