Drug

Who makes cocaine hydrochloride?

2 companies list cocaine hydrochloride as a human prescription drug, including under the names Goprelto, NUMBRINO. Forms: solution. Routes: nasal, topical. Counted across 2 spellings of the name in the directory, such as “cocaine hydrochloride”, “cocaine hydrochloride nasal”.

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 cocaine hydrochloride

CompanyFormsApplicationNDCsRegistered sites
LXO US Inc.solutionNDA, NDA AUTHORIZED GENERICNDA20996320
Omnivium Pharmaceuticals LLCsolutionNDA, NDA AUTHORIZED GENERICNDA20957520

Bulk ingredient listings

Orange Book patents

12 unexpired patents list cocaine hydrochloride as the active ingredient, expiring between Feb 2037 and Feb 2037. Application holders: LXO IRELAND DESIGNATED ACTIVITY CO, OMNIVIUM PHARMACEUTICALS LLC.

Enquiry

Common questions

Who makes cocaine hydrochloride?
2 companies list cocaine hydrochloride as a human prescription drug in the openFDA NDC Directory, led by LXO US Inc., Omnivium Pharmaceuticals LLC. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
Who supplies cocaine hydrochloride active ingredient?
3 companies list cocaine hydrochloride as a bulk ingredient, including MEDISCA Inc., SpecGx LLC, Spectrum Pharmaceuticals, Inc..