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NDC 66794-0155-02 Gablofen 500 ug/mL Details
Gablofen 500 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 | 66794-0155 |
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Product ID | 66794-155_f0943592-c2ad-4493-e053-2a95a90ac654 |
Associated GPIs | 7510001000E530 75100010002034 |
GCN Sequence Number | 070493 |
GCN Sequence Number Description | baclofen SYRINGE 10000/20ML INTRATHEC |
HIC3 | H6H |
HIC3 Description | SKELETAL MUSCLE RELAXANTS |
GCN | 34046 |
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 | 500 |
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 66794-0155-02 (66794015502)
NDC Package Code | 66794-155-02 |
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Billing NDC | 66794015502 |
Package | 20 mL in 1 VIAL, GLASS (66794-155-02) |
Marketing Start Date | 2017-04-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |