NDC 66794-156
Gablofen
Baclofen Injection
Gablofen is a Intrathecal Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Piramal Critical Care Inc. The primary component is Baclofen.
| Product ID | 66794-156_63af2eb8-696f-907b-e053-2991aa0a7c08 |
| NDC | 66794-156 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Gablofen |
| Generic Name | Baclofen Injection |
| Dosage Form | Injection, Solution |
| Route of Administration | INTRATHECAL |
| Marketing Start Date | 2017-04-01 |
| Marketing Category | NDA / NDA |
| Application Number | NDA022462 |
| Labeler Name | Piramal Critical Care Inc |
| Substance Name | BACLOFEN |
| Active Ingredient Strength | 1000 ug/mL |
| Pharm Classes | GABA A Agonists [MoA],GABA B Agonists [MoA],gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 66794-156-01
20 mL in 1 SYRINGE, GLASS (66794-156-01)
| Marketing Start Date | 2017-04-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 66794-156-02 [66794015602]
Gablofen INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022462 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-01 |
NDC 66794-156-01 [66794015601]
Gablofen INJECTION, SOLUTION
| Marketing Category | NDA |
| Application Number | NDA022462 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2017-04-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| BACLOFEN | 1000 ug/mL |
OpenFDA Data
| SPL SET ID: | 00d3e846-dd92-448d-9ab8-6a07be823cc1 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Pharmacological Class
- GABA A Agonists [MoA]
- GABA B Agonists [MoA]
- gamma-Aminobutyric Acid-ergic Agonist [EPC]
NDC Crossover Matching brand name "Gablofen" or generic name "Baclofen Injection"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 45945-156 | Gablofen | baclofen |
| 45945-157 | Gablofen | baclofen |
| 66794-151 | Gablofen | Baclofen Injection |
| 66794-155 | Gablofen | Baclofen Injection |
| 66794-156 | Gablofen | Baclofen Injection |
| 66794-157 | Gablofen | Baclofen Injection |
Trademark Results [Gablofen]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GABLOFEN 85457562 not registered Dead/Abandoned |
CNS Therapeutics, Inc. 2011-10-27 |
 GABLOFEN 77850392 4122201 Live/Registered |
PIRAMAL CRITICAL CARE, INC. 2009-10-16 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.