Prescription drug · ANDA
Baclofen NDC 0615-8467
Baclofen 20 mg/1 · Tablet · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8467-39 | 00615846739 | 30 TABLET in 1 BLISTER PACK (0615-8467-39)Marketed from May 18, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 20 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209102
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 0615-8467_9c2e25e4-823f-4ac2-82f4-674049807af5SPL ID 9c2e25e4-823f-4ac2-82f4-674049807af5SPL set ID 2927228a-7a3e-4e1d-ab5f-4407b00f6899RxCUI 197391, 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
N400615846739followed by a unit qualifier and the quantityPackage 00615-8467-39. 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, USP 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, USP 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, the…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209102
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 | Advagen Pharma Limited | 72888-010 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Advagen Pharma Limited | 72888-011 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-312 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-0949 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Advagen Pharma Limited | 72888-009 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4290 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4530 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-358 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-356 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Direct_Rx | 72189-504 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-357 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | Asclemed USA, Inc. | 76420-359 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | Proficient Rx LP | 82804-219 |
| Baclofen | Baclofen 5 mg/1 | TabletOral | TruPharma LLC | 52817-319 |
| Baclofen | Baclofen 15 mg/1 | TabletOral | TruPharma LLC | 52817-318 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | TruPharma LLC | 52817-320 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 71335-9638 |
| Baclofen | Baclofen 20 mg/1 | TabletOral | TruPharma LLC | 52817-321 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Advanced Rx of Tennessee, LLC | 80425-0568 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Proficient Rx LP | 82804-242 |
Showing 20 of 34.