Drug

Who makes hydrocodone bitartrate and homatropine methylbromide?

5 companies list hydrocodone bitartrate and homatropine methylbromide as a human prescription drug. Forms: solution; syrup; tablet. Routes: oral.

Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology

Companies listing hydrocodone bitartrate and homatropine methylbromide

CompanyFormsApplicationNDCsRegistered sites
Genus Lifesciences Inc.United Statessolution; tabletNDA AUTHORIZED GENERICNDA00521322
Novel Laboratories IncUnited Statessyrup; tabletANDAANDA091528, ANDA20353521
Lupin LimitedIndiatabletANDAANDA091528114
KVK-TECH, INC.United StatestabletANDAANDA20717612
PAI Holdings, LLCUnited StatessolutionNDA AUTHORIZED GENERICNDA00521311
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Common questions

Who makes hydrocodone bitartrate and homatropine methylbromide?
5 companies list hydrocodone bitartrate and homatropine methylbromide as a human prescription drug in the openFDA NDC Directory, led by Genus Lifesciences Inc., Novel Laboratories Inc, Lupin Limited, KVK-TECH, INC., PAI Holdings, LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Is there a generic hydrocodone bitartrate and homatropine methylbromide?
3 companies list hydrocodone bitartrate and homatropine methylbromide under an abbreviated new drug application (ANDA), the application type used for generics. Listing status is from the NDC Directory; it is not a statement of availability.