Quick answers
- What is Gablofen?
- Gablofen is a brand name of Baclofen, a prescription medicine. The FDA NDC Directory lists 4 Gablofen products in 4 strengths and forms.
- Who makes Gablofen?
- Piramal Critical holds the FDA application for Gablofen (NDA022462, approved November 19, 2010).
- Is there a generic or store brand of Gablofen?
- Yes. The FDA NDC Directory lists 4 other products with the same active ingredients, strength and form as a Gablofen product, 4 of them generic. Ask your pharmacist whether one is right for you.
- Has Gablofen been recalled?
- FDA enforcement reports list 1 recall of Gablofen products; the newest started July 8, 2019. A recall usually concerns specific lots, not every product.
What Gablofen is
Each Gablofen 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.
Baclofen · prescription medicine
| Strength and form | Product names | Same medicine, other names | Label |
|---|---|---|---|
| baclofen 1000 ug/mL injection, solution (intrathecal) | Gablofen | 1 product, 1 company | DailyMed |
| baclofen 2000 ug/mL injection, solution (intrathecal) | Gablofen | 1 product, 1 company | DailyMed |
| baclofen 50 ug/mL injection, solution (intrathecal) | Gablofen | 1 product, 1 company | DailyMed |
| baclofen 500 ug/mL injection, solution (intrathecal) | Gablofen | 1 product, 1 company | DailyMed |
Its page lists every product and company, the FDA label’s uses and boxed warning, approvals, shortages and recalls: Baclofen →
FDA approval
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Holder | First approved | Products |
|---|---|---|---|
| NDA022462 | Piramal Critical | November 19, 2010 | 4 |
Companies that list Gablofen
The company named on the package (holder, repackager or distributor), as listed in the FDA NDC Directory, with its number of Gablofen products.
- Piramal Critical Care Inc4 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.
-
July 8, 2019 · Class II · Terminated · D-1742-2019
Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.
Gablofen (baclofen injection), 50 mcg/mL, Single Use Syringe, Rx only, packaged in a box containing one 1 mL syringe, Distributed by: Primal Critical Care, Inc., 3950 Schelden Circle Bethlehem, PA, 18017, NDC 66794-151-0 — Piramal Critical Care, Inc.
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.