Prescription drug · ANDA
Baclofen NDC 67296-1947
Baclofen 10 mg/1 · Tablet · Oral · Redpharm Drug
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67296-1947-3 | 67296194703 | 30 TABLET in 1 BOTTLE (67296-1947-3)Marketed from Jul 9, 2020 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Redpharm Drug
- 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 67296-1947_4ce1d392-143a-3a00-e063-6294a90a3f9eSPL ID 4ce1d392-143a-3a00-e063-6294a90a3f9eSPL set ID 4ce1de84-72e1-57d3-e063-6294a90a220fRxCUI 197391UNII 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
N467296194703followed by a unit qualifier and the quantityPackage 67296-1947-03. 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)
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 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0459 |
| 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 |