NDC 66794-157 – Gablofen
Baclofen 2000 ug/mL · Injection, Solution · Intrathecal
Product NDC66794-157
Product details
- Brand name
- Gablofen
- Generic name
- Baclofen Injection
- Labeler
- Piramal Critical Care Inc
- Dosage form
- Injection, Solution
- Route
- Intrathecal
- Marketing category
- NDA · NDA022462
- Marketed since
- April 1, 2017
- Listing expires
- December 31, 2027
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
Active ingredients
- Baclofen 2000 ug/mL
Package NDC codes (2)
| Package NDC | Description | Since |
|---|---|---|
| 66794-157-01 | 20 mL in 1 SYRINGE, GLASS (66794-157-01) | Apr 1, 2017 |
| 66794-157-02 | 20 mL in 1 VIAL, GLASS (66794-157-02) | Apr 1, 2017 |
Recalls mentioning this NDC
- D-1742-2019 Aug 7, 2019 · Class II
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.