Source: FDA, National Drug Code (US) Revision Year: 2021
GABLOFEN (baclofen injection) is a muscle relaxant and antispastic. Baclofen’s pharmacological class is a gamma-aminobutyric acid (GABA) ergic agonist. Baclofen’s chemical name is 4-amino-3-(4-chlorophenyl) butanoic acid, and its structural formula is:
Baclofen
C10H12ClNO2
Baclofen is a white to off-white powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol and ethanol, practically insoluble in acetone and ether, soluble in 0.1N hydrochloric acid, 0.1N sodium hydroxide, and insoluble in chloroform.
GABLOFEN is a sterile, pyrogen-free, isotonic solution free of antioxidants, preservatives or other potentially neurotoxic additives indicated only for intrathecal administration. The drug is stable in solution at 37°C and compatible with CSF. Each mL of GABLOFEN contains baclofen USP 50 mcg, 500 mcg, 1,000 mcg or 2,000 mcg and sodium chloride 9 mg in Water for Injection; pH range is 5.5 to 7.5.
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GABLOFEN (baclofen injection) is available, for intrathecal use only, in:
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GABLOFEN (baclofen injection) is a sterile, pyrogen-free, isotonic solution available in a single-dose syringe of 1 mL containing 50 mcg (50 mcg/mL) and in single-dose syringes and vials of 10,000 mcg per 20 mL (500 mcg/mL), 20,000 mcg per 20 mL (1,000 mcg/mL), and 40,000 mcg per 20 mL (2,000 mcg/mL) for intrathecal administration only. 50 mcg per mL NDC 66794-151-01: 1 mL Syringe – 50 mcg per 1 mL 500 mcg per mL NDC 66794-155-01: 20 mL Syringe – 10,000 mcg per 20 mL NDC 66794-155-02: 20 mL Vial – 10,000 mcg per 20 mL 1,000 mcg per mL NDC 66794-156-01: 20 mL Syringe – 20,000 mcg per 20 mL NDC 66794-156-02: 20 mL Vial – 20,000 mcg per 20 mL 2,000 mcg per mL NDC 66794-157-01: 20 mL Syringe – 40,000 mcg per 20 mL NDC 66794-157-02: 20 mL Vial – 40,000 mcg per 20 mL Distributed By: Piramal Critical Care, Inc., 3950 Schelden Circle, Bethlehem, PA 18017, USA, Phone: 888 822 8431 |
| Drug | Countries | |
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| GABLOFEN | Netherlands, United States |
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