Prescription drug · ANDA
Baclofen NDC 80425-0459
Baclofen 20 mg/1 · Tablet · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0459-1 | 80425045901 | 30 TABLET in 1 BOTTLE (80425-0459-1)Marketed from Dec 18, 2024 | |
| 80425-0459-2 | 80425045902 | 60 TABLET in 1 BOTTLE (80425-0459-2)Marketed from Dec 18, 2024 | |
| 80425-0459-3 | 80425045903 | 90 TABLET in 1 BOTTLE (80425-0459-3)Marketed from Dec 18, 2024 | |
| 80425-0459-4 | 80425045904 | 120 TABLET in 1 BOTTLE (80425-0459-4)Marketed from Dec 18, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212067
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 80425-0459_29a64de5-af3e-5a91-e063-6394a90ac35cSPL ID 29a64de5-af3e-5a91-e063-6394a90ac35cSPL set ID 29987a4c-cf5f-4f98-e063-6394a90a7f19RxCUI 197392UNII 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
N480425045901followed by a unit qualifier and the quantityPackage 80425-0459-01. 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 tablets 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 tablets in stroke, cerebral palsy, and Parkinson's disease has not been established and, th…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212067
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 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2392 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2448 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2449 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-2450 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8783 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4249 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | PHOENIX RX LLC | 85509-1344 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-343 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-344 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2756 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Unichem Pharmaceuticals (USA), Inc. | 29300-474 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0391 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-4162 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Redpharm Drug | 67296-1947 |