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Data / Drug companies / Hydrocodone bitartrate and homatropine methylbromide

Hydrocodone bitartrate and homatropine methylbromide: 5 companies and 7 products in the FDA NDC directory

Updated November 6, 2026. Source: US Food and Drug Administration, National Drug Code Directory (openFDA).

Hydrocodone bitartrate and homatropine methylbromide is listed in the FDA National Drug Code Directory by 5 companies, with 7 products in commercial distribution. 4 of the products (57.1%) are marketed under an abbreviated new drug application (ANDA), the generic route. The most common dosage forms are tablet; solution; syrup, and the newest product started marketing on August 5, 2024.

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Companies listing it
5
Products
7
Generic (ANDA) products
4 (57.1%)
Application numbers
4
Controlled substance schedule
Schedule II
Routes
Oral
openFDA record search
api.fda.gov

Companies that list hydrocodone bitartrate and homatropine methylbromide

Ranked by number of products. Finished drugs in commercial distribution.

CompanyProductsMain dosage formsMain marketing categoryNewest product started
Genus Lifesciences2tablet; solutionAuthorized generics (NDA)August 10, 2022
Novel Laboratories, Inc.2tablet; syrupGeneric drugs (ANDA)February 13, 2017
KVK-Tech, Inc.1tabletGeneric drugs (ANDA)August 7, 2017
Lupin Pharmaceuticals,Inc.1tabletGeneric drugs (ANDA)September 23, 2014
Pai Holdings, LLC DBA Pai Pharma1solutionAuthorized generics (NDA)August 5, 2024

Dosage forms

Dosage formProductsShare
Tablet457.1%
Solution228.6%
Syrup114.3%

Marketing categories

Marketing categoryProductsShare
Generic drugs (ANDA)457.1%
Authorized generics (NDA)342.9%

Pharmacologic classes

ClassProducts
Opioid Agonist7

CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.