Quick answers
- What is Prolate?
- Prolate is a brand name of Oxycodone and acetaminophen, a prescription medicine. The FDA NDC Directory lists 4 Prolate products in 4 strengths and forms.
- Who makes Prolate?
- Pharmobedient holds the FDA application for Prolate (ANDA040608, approved December 30, 2005).
- Is there a generic or store brand of Prolate?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Prolate product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Prolate been recalled?
- No recall linked to Prolate products (by their NDC code or label) appears in the FDA enforcement reports we use.
What Prolate is
Each Prolate product as listed in the FDA NDC Directory, by active ingredient, strength and form, with its official label. “Same medicine, other names” counts the other products with exactly the same active ingredients, strength and form (generic versions, store brands and other brands); inactive ingredients can differ.
Oxycodone and acetaminophen · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| acetaminophen 300 mg · oxycodone hydrochloride 10 mg tablet (oral) | Prolate | 1 product, 1 company | DailyMed |
| acetaminophen 300 mg · oxycodone hydrochloride 5 mg tablet (oral) | Prolate | 1 product, 1 company | DailyMed |
| acetaminophen 300 mg · oxycodone hydrochloride 7.5 mg tablet (oral) | Prolate | 1 product, 1 company | DailyMed |
| acetaminophen 300 mg/5 mL · oxycodone hydrochloride 10 mg/5 mL solution (oral) | Prolate | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Oxycodone and acetaminophen →
FDA approval
- ANDA: Abbreviated New Drug Application: how a generic version is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| ANDA040608 | Pharmobedient | December 30, 2005 | 3 |
| ANDA202142 | Pharmobedient | November 27, 2018 | 1 |
Companies that list Prolate
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Prolate products.
- Forte Bio-Pharma LLC4 products
Recalls
No recall linked to Prolate products (by their NDC code or label) appears in the FDA enforcement reports.
Sources
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug labeling (SPL, openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- NADAC (National Average Drug Acquisition Cost) 2026 — Centers for Medicare & Medicaid Services (CMS), data.medicaid.gov, list of November 4, 2026, retrieved November 7, 2026
Which names get a brand page: a name the NDC Directory lists for a medicine, held by one company (the FDA application holder, or the company named on most of its products), that is not just a description, and that is not the only product of its medicine.