Drug

Who makes oxycodone hydrochloride and acetaminophen?

5 companies list oxycodone hydrochloride and acetaminophen as a human prescription drug, including under the names PERCOCET, Prolate. Forms: solution; 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 oxycodone hydrochloride and acetaminophen

CompanyFormsApplicationNDCsRegistered sites
SpecGx LLCUnited StatestabletANDAANDA040330, ANDA040545, ANDA08746365
Elite Laboratories, Inc.United StatestabletANDAANDA20938531
St. Mary's Medical Park PharmacyUnited StatestabletANDAANDA20938531
FH2 Pharma LLCsolutionANDAANDA20214210
Forte Bio-Pharma LLCsolutionANDAANDA20214210
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Common questions

Who makes oxycodone hydrochloride and acetaminophen?
5 companies list oxycodone hydrochloride and acetaminophen as a human prescription drug in the openFDA NDC Directory, led by SpecGx LLC, Elite Laboratories, Inc., St. Mary's Medical Park Pharmacy, FH2 Pharma LLC, Forte Bio-Pharma 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 oxycodone hydrochloride and acetaminophen?
5 companies list oxycodone hydrochloride and acetaminophen 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.