Prescription drug · NDA
Lyvispah (Baclofen) NDC 64896-078
Baclofen 20 mg/1 · Granule · Oral · Amneal Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64896-078-09 | 6489600780964896007809 | 90 PACKET in 1 CARTON (64896-078-09) / 1 GRANULE in 1 PACKETMarketed from Jun 1, 2023 |
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)
- Lyvispah
- Generic name (nonproprietary)
- baclofen
- Active ingredients
- Baclofen — 20 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals LLCNDC labeler code 64896
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 215422
- Marketing start
- Listing expires
- Other FDA classes
- GABA A Agonists (Mechanism)GABA B Agonists (Mechanism)
- Identifiers
- Product ID 64896-078_d042d45f-7097-47e0-921f-0442e00d47e0SPL ID d042d45f-7097-47e0-921f-0442e00d47e0SPL set ID f8992a56-9010-4c4b-84d5-ddcc3e2c3317RxCUI 2586589, 2586595, 2586596, 2586598, 2586599, 2586601UNII H789N3FKE8UPC 0364896077097, 0364896078094, 0364896076090
- 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
N464896007809followed by a unit qualifier and the quantityPackage 64896-0078-09. 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)
LYVISPAH 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. LYVISPAH may also be of some value in patients with spinal cord injuries and other spinal cord diseases. Limitations of Use LYVISPAH is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders. LYVISPAH 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 rigidity. ( 1 ) LYVISPAH may also be of some value in patient…
Excerpt only. Read the full label for complete information.
About NDC 64896-078
- What is NDC 64896-078?
- 64896-078 is the product NDC for Lyvispah (baclofen), Baclofen 20 mg/1 granule, listed with the FDA by Amneal Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lyvispah (Baclofen).
- What is the active ingredient?
- Baclofen.
- Who is the labeler?
- Amneal Pharmaceuticals LLC, NDC labeler code 64896. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lyvispah?
- 3 other product NDCs are listed under this name. See all Lyvispah NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lyvispah products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lyvispahbaclofen | Baclofen 10 mg/1 | GranuleOral | Anvi Pharmaceuticals Inc | 87519-003 | 87519-0003-90 |
| Lyvispahbaclofen | Baclofen 5 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-076 | 64896-0076-09 |
| Lyvispahbaclofen | Baclofen 10 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-077 | 64896-0077-09 |
Other NDCs under NDA 215422
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 |
|---|---|---|---|---|
| Lyvispahbaclofen | Baclofen 5 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-076 |
| Lyvispahbaclofen | Baclofen 10 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-077 |
| Lyvispahbaclofen | Baclofen 10 mg/1 | GranuleOral | Anvi Pharmaceuticals Inc | 87519-003 |