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NDC 67457-0563-20 baclofen 1000 ug/mL Details
baclofen 1000 ug/mL
baclofen is a INTRATHECAL INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Mylan Institutional LLC. The primary component is BACLOFEN.
Product Information
| NDC | 67457-0563 |
|---|---|
| Product ID | 67457-563_7fad5721-cafc-4f49-a265-b15c057b5c76 |
| Associated GPIs | 75100010002039 |
| GCN Sequence Number | 069400 |
| GCN Sequence Number Description | baclofen VIAL 20K MCG/20 INTRATHEC |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 32435 |
| HICL Sequence Number | 001949 |
| HICL Sequence Number Description | BACLOFEN |
| Brand/Generic | Generic |
| Proprietary Name | baclofen |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | baclofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRATHECAL |
| Active Ingredient Strength | 1000 |
| Active Ingredient Units | ug/mL |
| Substance Name | BACLOFEN |
| Labeler Name | Mylan Institutional LLC |
| Pharmaceutical Class | GABA A Agonists [MoA], GABA B Agonists [MoA], gamma-Aminobutyric Acid-ergic Agonist [EPC] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA209594 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 67457-0563-20 (67457056320)
| NDC Package Code | 67457-563-20 |
|---|---|
| Billing NDC | 67457056320 |
| Package | 1 VIAL, GLASS in 1 CARTON (67457-563-20) / 20 mL in 1 VIAL, GLASS |
| Marketing Start Date | 2018-12-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |