Prescription drug · NDA AUTHORIZED GENERIC
Baclofen NDC 17856-0620
Baclofen 10 mg/5mL · Solution · Oral · Atlantic Biologicals Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0620-1 | 17856062001 | 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-1) / 2.5 mL in 1 CUP, UNIT-DOSEMarketed from Apr 30, 2026 | |
| 17856-0620-2 | 17856062002 | 72 CUP, UNIT-DOSE in 1 CASE (17856-0620-2) / 5 mL in 1 CUP, UNIT-DOSEMarketed from Apr 30, 2026 | |
| 17856-0620-3 | 17856062003 | 1 SYRINGE in 1 BAG (17856-0620-3) / 2.5 mL in 1 SYRINGEMarketed from Jul 14, 2026 | |
| 17856-0620-4 | 17856062004 | 1 SYRINGE in 1 BAG (17856-0620-4) / 5 mL in 1 SYRINGEMarketed from Jul 14, 2026 | |
| 17856-0620-5 | 17856062005 | 45 SYRINGE in 1 BOX, UNIT-DOSE (17856-0620-5) / 5 mL in 1 SYRINGEMarketed from Sep 4, 2026 | |
| 17856-0620-9 | 17856062009 | 90 SYRINGE in 1 BOX, UNIT-DOSE (17856-0620-9) / 2.5 mL in 1 SYRINGEMarketed from Sep 4, 2026 |
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/5mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Atlantic Biologicals Corp.
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 208193
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 17856-0620_5aae5fc2-e3b8-4974-e063-6294a90a113dSPL ID 5aae5fc2-e3b8-4974-e063-6294a90a113dSPL set ID 50b3e7be-832b-313d-e063-6394a90a5ab4RxCUI 2667941UNII 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
N417856062001followed by a unit qualifier and the quantityPackage 17856-0620-01. 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)
Baclofen oral solution is indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. Baclofen oral solution may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use Baclofen oral solution is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. Baclofen oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist indicated for the treatment of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigid…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 208193
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/5mL | SolutionOral | Palmetto Pharmaceuticals Inc. | 68134-403 |
| Baclofen | Baclofen 10 mg/5mL | SolutionOral | TRUPHARMA, LLC | 52817-620 |
| Ozobax Dsbaclofen | Baclofen 10 mg/5mL | SolutionOral | Rosemont Pharmaceuticals LLC | 69528-302 |