hydrocodone bitartrate and homatropine methylbromide

Generic: hydrocodone bitartrate and homatropine methylbromide

Labeler: novel laboratories, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocodone bitartrate and homatropine methylbromide
Generic Name hydrocodone bitartrate and homatropine methylbromide
Labeler novel laboratories, inc.
Dosage Form SYRUP
Routes
ORAL
Active Ingredients

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

Manufacturer
Novel Laboratories, Inc.

Identifiers & Regulatory

Product NDC 40032-810
Product ID 40032-810_c524711b-29fd-41d1-b026-072e7314b06a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA203535
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2017-02-13

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 40032810
Hyphenated Format 40032-810

Supplemental Identifiers

RxCUI
992668
UPC
0340032810056
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 hydrocodone bitartrate and homatropine methylbromide (source: ndc)
Generic Name hydrocodone bitartrate and homatropine methylbromide (source: ndc)
Application Number ANDA203535 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (40032-810-05)
source: ndc

Packages (1)

40032-810-05 473 mL in 1 BOTTLE (40032-810-05)

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": "c524711b-29fd-41d1-b026-072e7314b06a", "openfda": {"upc": ["0340032810056"], "unii": ["68JRS2HC1C", "NO70W886KK"], "rxcui": ["992668"], "spl_set_id": ["4050ae05-7f1a-48b7-99b9-f8db8aa02741"], "manufacturer_name": ["Novel Laboratories, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "473 mL in 1 BOTTLE (40032-810-05)", "package_ndc": "40032-810-05", "marketing_start_date": "20170213"}], "brand_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "product_id": "40032-810_c524711b-29fd-41d1-b026-072e7314b06a", "dosage_form": "SYRUP", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "40032-810", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "labeler_name": "Novel Laboratories, 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": "ANDA203535", "marketing_category": "ANDA", "marketing_start_date": "20170213", "listing_expiration_date": "20261231"}