Prescription drug · ANDA
Baclofen NDC 62559-204
Baclofen 5 mg/mL · Suspension · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62559-204-03 | 62559020403 | 1 BOTTLE in 1 CARTON (62559-204-03) / 300 mL in 1 BOTTLEMarketed from Mar 19, 2024 | |
| 62559-204-12 | 62559020412 | 1 BOTTLE in 1 CARTON (62559-204-12) / 120 mL in 1 BOTTLEMarketed from Mar 18, 2024 |
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)
- Baclofen
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 5 mg/mL
- Dosage form
- Suspension
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217252
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 62559-204_1c95cf7d-6db8-437d-9e33-f8ecb151eca6SPL ID 1c95cf7d-6db8-437d-9e33-f8ecb151eca6SPL set ID c73ed3af-8e8a-4a18-90fc-a0f2dcc641d0RxCUI 2593376UNII 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
N462559020403followed by a unit qualifier and the quantityPackage 62559-0204-03. 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)
Baclofen oral suspension 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. Baclofen oral suspension may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral suspension is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. • Baclofen oral suspension 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 musc…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 217252
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/mL | SuspensionOral | Slayback Pharma LLC | 71225-140 |