Prescription drug · NDA
Lyrica (pregabalin) NDC 58151-244
Pregabalin 20 mg/mL · Solution · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-244-35 | 58151024435 | 473 mL in 1 BOTTLE (58151-244-35)Marketed from Oct 22, 2024 |
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)
- Lyrica
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 20 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Viatris Specialty LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022488
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 58151-244_1c2af07d-faf4-4fc7-b724-c5166746956dSPL ID 1c2af07d-faf4-4fc7-b724-c5166746956dSPL set ID d4734e7d-5079-455e-8ff5-8f4539c998a9RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127, 607018, 607020, 607022, 607024, 607026, 607028, 607033, 607038, 898715, 898718UNII 55JG375S6MUPC 0358151240777, 0358151236770, 0358151239771, 0358151241774, 0358151238774, 0358151242771
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
N458151024435followed by a unit qualifier and the quantityPackage 58151-0244-35. 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)
LYRICA is indicated for: • Management of neuropathic pain associated with diabetic peripheral neuropathy • Management of postherpetic neuralgia • Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury LYRICA is indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic neuralgia (PHN) ( 1 ) • Adjunctive therapy for the treatment of partial‑onset seizures in patients 1 month of age and older ( 1 ) • Fibromyalgia ( 1 ) • Neuropathic pain associated with spinal cord injury ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022488
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 |
|---|---|---|---|---|
| Pregabalin | Pregabalin 20 mg/mL | SolutionOral | Mylan Pharmaceuticals Inc. | 59762-1576 |