Prescription drug · ANDA
Baclofen NDC 55289-757
Baclofen 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55289-757-30 | 55289075730 | 30 TABLET in 1 BOTTLE, PLASTIC (55289-757-30)Marketed from Mar 24, 2009 | |
| 55289-757-60 | 55289075760 | 60 TABLET in 1 BOTTLE, PLASTIC (55289-757-60)Marketed from Mar 24, 2009 | |
| 55289-757-90 | 55289075790 | 90 TABLET in 1 BOTTLE, PLASTIC (55289-757-90)Marketed from Dec 26, 2007 |
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 — 10 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 072234
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 55289-757_419b4e87-cb86-8fbc-e063-6394a90a3b7cSPL ID 419b4e87-cb86-8fbc-e063-6394a90a3b7cSPL set ID 95755a7b-4a9f-45ea-a381-d3f661150efeRxCUI 197391UNII H789N3FKE8UPC 0355289757306
- 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
N455289075730followed by a unit qualifier and the quantityPackage 55289-0757-30. 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 072234
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 | Teva Pharmaceuticals USA, Inc. | 0172-4096 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Northwind Health Company, LLC | 82868-013 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0080 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Proficient Rx LP | 63187-147 |