Prescription drug · NDA
Lyvispah (Baclofen) NDC 87519-003
Baclofen 10 mg/1 · Granule · Oral · Anvi Pharmaceuticals Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 87519-003-90 | 87519000390 | 90 PACKET in 1 CARTON (87519-003-90) / 1 GRANULE in 1 PACKETMarketed from Sep 1, 2026 |
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 — 10 mg/1
- Dosage form
- Granule
- Route
- Oral
- Labeler
- Anvi Pharmaceuticals IncNDC labeler code 87519
- 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 87519-003_5c18f6d4-5f52-0cb7-e063-6294a90a835eSPL ID 5c18f6d4-5f52-0cb7-e063-6294a90a835e
- 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
N487519000390followed by a unit qualifier and the quantityPackage 87519-0003-90. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 87519-003
- What is NDC 87519-003?
- 87519-003 is the product NDC for Lyvispah (baclofen), Baclofen 10 mg/1 granule, listed with the FDA by Anvi Pharmaceuticals Inc. 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?
- Anvi Pharmaceuticals Inc, NDC labeler code 87519. 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 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 |
| Lyvispahbaclofen | Baclofen 20 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-078 | 64896-0078-09 |
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 20 mg/1 | GranuleOral | Amneal Pharmaceuticals LLC | 64896-078 |