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NDC 69528-0302-16 OZOBAX 10 mg/5mL Details
OZOBAX 10 mg/5mL
OZOBAX is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Metacel Pharmaceuticals, LLC. The primary component is BACLOFEN.
MedlinePlus Drug Summary
Baclofen is used to treat pain and certain types of spasticity (muscle stiffness and tightness) from multiple sclerosis, spinal cord injuries, or other spinal cord diseases. Baclofen is in a class of medications called skeletal muscle relaxants. Baclofen acts on the spinal cord nerves and decreases the number and severity of muscle spasms caused by multiple sclerosis or spinal cord conditions. It also relieves pain and improves muscle movement.
Related Packages: 69528-0302-16Last Updated: 05/05/2024
MedLinePlus Full Drug Details: Baclofen
Product Information
| NDC | 69528-0302 |
|---|---|
| Product ID | 69528-302_dd9c8f4b-836c-4fdc-96cb-37042fa6dfcb |
| Associated GPIs | |
| GCN Sequence Number | 085432 |
| GCN Sequence Number Description | baclofen SOLUTION 10 MG/5 ML ORAL |
| HIC3 | H6H |
| HIC3 Description | SKELETAL MUSCLE RELAXANTS |
| GCN | 54913 |
| HICL Sequence Number | 001949 |
| HICL Sequence Number Description | BACLOFEN |
| Brand/Generic | Brand |
| Proprietary Name | OZOBAX |
| Proprietary Name Suffix | DS |
| Non-Proprietary Name | Baclofen |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mg/5mL |
| Substance Name | BACLOFEN |
| Labeler Name | Metacel Pharmaceuticals, LLC |
| 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 | NDA208193 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69528-0302-16 (69528030216)
| NDC Package Code | 69528-302-16 |
|---|---|
| Billing NDC | 69528030216 |
| Package | 473 mL in 1 BOTTLE (69528-302-16) |
| Marketing Start Date | 2023-10-12 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |