Prescription drug · ANDA
Baclofen NDC 0615-8518
Baclofen 5 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8518-05 | 00615851805 | 15 TABLET in 1 BLISTER PACK (0615-8518-05)Marketed from Aug 14, 2024 | |
| 0615-8518-39 | 00615851839 | 30 TABLET in 1 BLISTER PACK (0615-8518-39)Marketed from Aug 14, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Baclofen
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 5 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215885
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 0615-8518_8c1dfdbe-e30f-436d-882e-8b4c5f8ca29aSPL ID 8c1dfdbe-e30f-436d-882e-8b4c5f8ca29aSPL set ID ea4ad5c5-207c-4a68-8e6e-4ff101777e5cRxCUI 430902UNII 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
N400615851805followed by a unit qualifier and the quantityPackage 00615-8518-05. 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)
INDICATIONS AND USAGE Baclofen tablets are useful for the alleviation of signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Patients should have reversible spasticity so that baclofen treatment will aid in restoring residual function. Baclofen tablets may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Baclofen tablets are not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. The efficacy of baclofen in stroke, cerebral palsy, and Parkinson's disease has not been established and, therefore, it is n…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215885
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Baclofen | Baclofen 5 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-972 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-973 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Golden State Medical Supply, Inc. | 51407-974 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-085 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-288 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Lifestar Pharma LLC | 70756-289 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-0198 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-921 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-924 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4378 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7552 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Major Pharmaceuticals | 0904-7553 |