Prescription drug · ANDA
Baclofen NDC 16571-169
Baclofen 5 mg/1 · Tablet · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 16571-169-01 | 16571016901 | 100 TABLET in 1 BOTTLE (16571-169-01)Marketed from Mar 1, 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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214374
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 16571-169_ff66a259-5803-47a3-9558-87acf43f43a7SPL ID ff66a259-5803-47a3-9558-87acf43f43a7SPL set ID 6eb46715-d72b-473f-b984-90024033d4a0RxCUI 197391, 197392, 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
N416571016901followed by a unit qualifier and the quantityPackage 16571-0169-01. 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 treatment will aid in restoring residual function. Baclofen tablets, USP 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214374
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 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4235 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0478 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-171 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 16571-172 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | NuCare Pharmaceuticals, Inc. | 68071-3700 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-2497 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Direct_rx | 72189-565 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4384 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8726 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-3050 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Preferred Pharmaceuticals Inc. | 68788-8737 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9759 |