hydrocodone bitartrate and homatropine methylbromide

Generic: hydrocodone bitartrate and homatropine methylbromide oral solution

Labeler: kvk-tech, 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 oral solution
Labeler kvk-tech, inc.
Dosage Form LIQUID
Routes
ORAL
Active Ingredients

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

Manufacturer
KVK-Tech, Inc.

Identifiers & Regulatory

Product NDC 10702-150
Product ID 10702-150_47b998e5-ead4-9500-e063-6294a90a79ba
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA207487
DEA Schedule cii
Listing Expiration 2027-12-31
Marketing Start 2017-02-21

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 10702150
Hyphenated Format 10702-150

Supplemental Identifiers

RxCUI
992668
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 oral solution (source: ndc)
Application Number ANDA207487 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/5mL
  • 5 mg/5mL
source: ndc
Packaging
  • 473 mL in 1 BOTTLE (10702-150-16)
source: ndc

Packages (1)

10702-150-16 473 mL in 1 BOTTLE (10702-150-16)

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": "47b998e5-ead4-9500-e063-6294a90a79ba", "openfda": {"unii": ["68JRS2HC1C", "NO70W886KK"], "rxcui": ["992668"], "spl_set_id": ["9a737416-08e0-4df6-897e-cf9d1b5f0b01"], "manufacturer_name": ["KVK-Tech, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "473 mL in 1 BOTTLE (10702-150-16)", "package_ndc": "10702-150-16", "marketing_start_date": "20170221"}], "brand_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "product_id": "10702-150_47b998e5-ead4-9500-e063-6294a90a79ba", "dosage_form": "LIQUID", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "10702-150", "dea_schedule": "CII", "generic_name": "hydrocodone bitartrate and homatropine methylbromide oral solution", "labeler_name": "KVK-Tech, 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": "ANDA207487", "marketing_category": "ANDA", "marketing_start_date": "20170221", "listing_expiration_date": "20271231"}