Quick answers
- What is Paxil CR?
- Paxil CR is a brand name of Paroxetine, a prescription medicine. The FDA NDC Directory lists 3 Paxil CR products in 3 strengths and forms.
- Who makes Paxil CR?
- Apotex holds the FDA application for Paxil CR (NDA020936, approved February 16, 1999).
- Is there a generic or store brand of Paxil CR?
- Yes. The FDA NDC Directory lists 10 other products with the same active ingredients, strength and form as a Paxil CR product, 10 of them generic. Ask your pharmacist whether one is right for you.
- What do pharmacies pay for Paxil CR?
- CMS lists a National Average Drug Acquisition Cost (NADAC) for 1 Paxil CR strength and form (see the table below). That is what pharmacies pay to buy it, not what you pay: your price depends on your insurance and your pharmacy.
- Has Paxil CR been recalled?
- FDA enforcement reports list 1 recall of Paxil CR products; the newest started August 13, 2026. A recall usually concerns specific lots, not every product.
What Paxil CR is
Each Paxil CR 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.
Paroxetine · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| paroxetine hydrochloride 12.5 mg tablet, film coated, extended release (oral) | Paxil CR | 4 products, 4 companies | — |
| paroxetine hydrochloride 25 mg tablet, film coated, extended release (oral) | Paxil CR | 3 products, 3 companies | — |
| paroxetine hydrochloride 37.5 mg tablet, film coated, extended release (oral) | Paxil CR | 3 products, 3 companies | — |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Paroxetine →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA020936 | Apotex | February 16, 1999 | 3 |
What pharmacies pay (NADAC)
The National Average Drug Acquisition Cost (NADAC) is the average price U.S. retail pharmacies paid to buy one unit of a medicine (one tablet, one mL or one gram), from a monthly survey of pharmacy invoices by the Centers for Medicare & Medicaid Services (CMS). State Medicaid programs use it to pay pharmacies.
This is not the price you pay. What you pay depends on your insurance (copay or coinsurance), your pharmacy and any discounts, and pharmacies also charge for filling a prescription. Ask your pharmacist or your health plan what your price will be.
| Strength and form | Generic or brand | Pharmacies pay |
|---|---|---|
| paroxetine hydrochloride 25 mg tablet, film coated, extended release | Brand: Paxil CR | $10.80 per tablet Generic of the same strength and form: $0.3980 per tablet |
NADAC list of November 4, 2026; these prices took effect on August 19, 2026. Shown only where a package’s NDC code matches the NADAC list exactly, and only for that exact strength and form: nothing is averaged across strengths. Strengths and forms not listed here have no NADAC price.
Source: NADAC (National Average Drug Acquisition Cost) 2026, data.medicaid.gov (CMS) →
Companies that list Paxil CR
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Paxil CR products.
- Apotex Corp3 products
Recalls
From FDA enforcement reports, matched by the product’s NDC code or label. A recall usually covers specific lots: check the lot number on your package and ask your pharmacist. Do not stop a medicine on your own.
-
August 13, 2026 · Class II · Ongoing · D-0804-2026
Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3 — Apotex Corp.
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.