Prescription drug · NDA
Lyrica CR (Pregabalin) NDC 58151-246
Pregabalin 165 mg/1 · Tablet, Film coated, Extended release · Oral · Viatris Specialty LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58151-246-93 | 58151024693 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (58151-246-93)Marketed from Nov 26, 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 CR
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 165 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Viatris Specialty LLCNDC labeler code 58151
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 209501
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 58151-246_67715d17-5ade-44ba-a5db-ba20d30d6da1SPL ID 67715d17-5ade-44ba-a5db-ba20d30d6da1SPL set ID f280bbd8-2af2-444a-bd96-e409337ca6ddRxCUI 1988974, 1988977, 1988980, 1994389, 1994392, 1994395UNII 55JG375S6M
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
N458151024693followed by a unit qualifier and the quantityPackage 58151-0246-93. 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 CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy • Postherpetic neuralgia Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. LYRICA CR is indicated for the management of: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) • Postherpetic neuralgia (PHN) ( 1 ) Efficacy of LYRICA CR has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures.
Excerpt only. Read the full label for complete information.
About NDC 58151-246
- What is NDC 58151-246?
- 58151-246 is the product NDC for Lyrica CR (pregabalin), Pregabalin 165 mg/1 tablet, film coated, extended release, listed with the FDA by Viatris Specialty LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lyrica CR (Pregabalin).
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Viatris Specialty LLC, NDC labeler code 58151. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lyrica CR?
- 2 other product NDCs are listed under this name. See all Lyrica CR NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lyrica CR products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lyrica CRpregabalin | Pregabalin 82.5 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-245 | 58151-0245-93 |
| Lyrica CRpregabalin | Pregabalin 330 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-247 | 58151-0247-93 |
Other NDCs under NDA 209501
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 |
|---|---|---|---|---|
| Lyrica CRpregabalin | Pregabalin 82.5 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-245 |
| Lyrica CRpregabalin | Pregabalin 330 mg/1 | Tablet, Film coated, Extended releaseOral | Viatris Specialty LLC | 58151-247 |