Prescription drug · NDA
Ozobax Ds (baclofen) NDC 69528-302
Baclofen 10 mg/5mL · Solution · Oral · Rosemont Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69528-302-08 | 69528030208 | 237 mL in 1 BOTTLE (69528-302-08)Marketed from Oct 12, 2023 | |
| 69528-302-16 | 69528030216 | 473 mL in 1 BOTTLE (69528-302-16)Marketed from Oct 12, 2023 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ozobax DsSuffix: DS
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 10 mg/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Rosemont Pharmaceuticals LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208193
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 69528-302_4ce95252-8c9b-2246-e063-6294a90a8b25SPL ID 4ce95252-8c9b-2246-e063-6294a90a8b25SPL set ID d8ddcec5-debe-42b4-a803-e65917cc6a54RxCUI 2667941, 2667943UNII H789N3FKE8
- Pharmacologic class
- gamma-Aminobutyric Acid-ergic Agonist
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N469528030208followed by a unit qualifier and the quantityPackage 69528-0302-08. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
OZOBAX DS is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. OZOBAX DS may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use OZOBAX DS is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. OZOBAX DS is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. ( 1 ) OZOBAX DS may also be of some value in pa…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208193
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.