Prescription drug · ANDA
Baclofen NDC 43063-864
Baclofen 10 mg/1 · Tablet · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-864-30 | 43063086430 | 30 TABLET in 1 BOTTLE, PLASTIC (43063-864-30)Marketed from Jun 26, 2018 | |
| 43063-864-60 | 43063086460 | 60 TABLET in 1 BOTTLE, PLASTIC (43063-864-60)Marketed from Jun 26, 2018 | |
| 43063-864-90 | 43063086490 | 90 TABLET in 1 BOTTLE, PLASTIC (43063-864-90)Marketed from Jun 26, 2018 |
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 078220
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 43063-864_415c3642-f324-746e-e063-6294a90a7ae0SPL ID 415c3642-f324-746e-e063-6294a90a7ae0SPL set ID cfcf519f-5d15-431d-89c8-961a0c38ba60RxCUI 197391, 197392UNII H789N3FKE8UPC 0343063865309, 0343063864906
- 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
N443063086430followed by a unit qualifier and the quantityPackage 43063-0864-30. 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 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, theref…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078220
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 | 71335-0344 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Major Pharmaceuticals | 0904-6475 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Lannett Company, Inc. | 0527-1330 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 72162-1079 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Preferred Pharmaceuticals, Inc. | 68788-9246 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-452 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2080 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2081 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Bryant Ranch Prepack | 63629-2082 |
| Baclofen | Baclofen 10 mg/1 | TabletOral | Cardinal Health 107, LLC | 55154-7635 |