hydromet

Generic: hydrocodone bitartrate and homatropine methylbromide

Labeler: actavis pharma, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydromet
Generic Name hydrocodone bitartrate and homatropine methylbromide
Labeler actavis pharma, inc.
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

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

Manufacturer
Actavis Pharma, Inc.

Identifiers & Regulatory

Product NDC 0472-1030
Product ID 0472-1030_6edda2e2-7ff0-4cc2-bd99-5a424bb6fbca
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA088017
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2002-09-30

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04721030
Hyphenated Format 0472-1030

Supplemental Identifiers

RxCUI
992668 992675
UPC
0304721030163
UNII
68JRS2HC1C 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 hydromet (source: ndc)
Generic Name hydrocodone bitartrate and homatropine methylbromide (source: ndc)
Application Number ANDA088017 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (0472-1030-16)
source: ndc

Packages (1)

0472-1030-16 473 mL in 1 BOTTLE (0472-1030-16)

Ingredients (2)

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

Linked Drug Pages (1)

Hydromet ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "6edda2e2-7ff0-4cc2-bd99-5a424bb6fbca", "openfda": {"upc": ["0304721030163"], "unii": ["68JRS2HC1C", "NO70W886KK"], "rxcui": ["992668", "992675"], "spl_set_id": ["a324c912-a3ef-4296-b9a8-b0fec687eb06"], "manufacturer_name": ["Actavis Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (0472-1030-16)", "package_ndc": "0472-1030-16", "marketing_start_date": "20020930"}], "brand_name": "Hydromet", "product_id": "0472-1030_6edda2e2-7ff0-4cc2-bd99-5a424bb6fbca", "dosage_form": "SOLUTION", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "0472-1030", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and homatropine methylbromide", "labeler_name": "Actavis Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydromet", "active_ingredients": [{"name": "HOMATROPINE METHYLBROMIDE", "strength": "1.5 mg/5mL"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/5mL"}], "application_number": "ANDA088017", "marketing_category": "ANDA", "marketing_start_date": "20020930", "listing_expiration_date": "20261231"}