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NDC 66794-0157-02 Gablofen 2000 ug/mL Details
Gablofen 2000 ug/mL
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 Information
| NDC | 66794-0157 |
|---|---|
| Product ID | 66794-157_f0943592-c2ad-4493-e053-2a95a90ac654 |
| Associated GPIs | 7510001000E550 75100010002050 |
| GCN Sequence Number | 070495 |
| GCN Sequence Number Description | baclofen SYRINGE 40000/20ML INTRATHEC |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 34048 |
| HICL Sequence Number | 001949 |
| HICL Sequence Number Description | BACLOFEN |
| Brand/Generic | Brand |
| Proprietary Name | Gablofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Baclofen Injection |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRATHECAL |
| Active Ingredient Strength | 2000 |
| Active Ingredient Units | ug/mL |
| Substance Name | BACLOFEN |
| Labeler Name | Piramal Critical Care Inc |
| Pharmaceutical Class | GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA022462 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 66794-0157-02 (66794015702)
| NDC Package Code | 66794-157-02 |
|---|---|
| Billing NDC | 66794015702 |
| Package | 20 mL in 1 VIAL, GLASS (66794-157-02) |
| Marketing Start Date | 2017-04-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |