hydrocodone bitartrate and homatropine methylbromide

Generic: hydrocodone bitartrate and homatropine methylbromide

Labeler: lupin pharmaceuticals,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 lupin pharmaceuticals,inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

homatropine methylbromide 1.5 mg/1, hydrocodone bitartrate 5 mg/1

Manufacturer
Lupin Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 43386-118
Product ID 43386-118_116df522-26b7-42de-8c0b-16cc60c2e764
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091528
DEA Schedule cii
Listing Expiration 2026-12-31
Marketing Start 2014-09-23

Pharmacologic Class

Classes
opioid agonist [epc] opioid agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 43386118
Hyphenated Format 43386-118

Supplemental Identifiers

RxCUI
992656
UPC
0343386118038
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 ANDA091528 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1.5 mg/1
  • 5 mg/1
source: ndc
Packaging
  • 100 TABLET in 1 BOTTLE (43386-118-01)
  • 30 TABLET in 1 BOTTLE (43386-118-03)
source: ndc

Packages (2)

43386-118-01 100 TABLET in 1 BOTTLE (43386-118-01) 43386-118-03 30 TABLET in 1 BOTTLE (43386-118-03)

Ingredients (2)

homatropine methylbromide (1.5 mg/1) hydrocodone bitartrate (5 mg/1)

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": "116df522-26b7-42de-8c0b-16cc60c2e764", "openfda": {"upc": ["0343386118038"], "unii": ["68JRS2HC1C", "NO70W886KK"], "rxcui": ["992656"], "spl_set_id": ["41ac90b3-f007-4eb2-9d41-ea626ced2017"], "manufacturer_name": ["Lupin Pharmaceuticals,Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": true, "description": "100 TABLET in 1 BOTTLE (43386-118-01)", "package_ndc": "43386-118-01", "marketing_start_date": "20140923"}, {"sample": true, "description": "30 TABLET in 1 BOTTLE (43386-118-03)", "package_ndc": "43386-118-03", "marketing_start_date": "20140923"}], "brand_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "product_id": "43386-118_116df522-26b7-42de-8c0b-16cc60c2e764", "dosage_form": "TABLET", "pharm_class": ["Opioid Agonist [EPC]", "Opioid Agonists [MoA]"], "product_ndc": "43386-118", "dea_schedule": "CII", "generic_name": "Hydrocodone Bitartrate and Homatropine Methylbromide", "labeler_name": "Lupin Pharmaceuticals,Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Hydrocodone Bitartrate and Homatropine Methylbromide", "active_ingredients": [{"name": "HOMATROPINE METHYLBROMIDE", "strength": "1.5 mg/1"}, {"name": "HYDROCODONE BITARTRATE", "strength": "5 mg/1"}], "application_number": "ANDA091528", "marketing_category": "ANDA", "marketing_start_date": "20140923", "listing_expiration_date": "20261231"}