Prescription drug · ANDA
Pregabalin NDC 58118-0759
Pregabalin 50 mg/1 · Capsule · Oral · Clinical Solutions Wholesale, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58118-0759-8 | 58118075908 | 30 CAPSULE in 1 BLISTER PACK (58118-0759-8)Marketed from Sep 9, 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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205321
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 58118-0759_5b13c06e-52c5-f2c7-e063-6294a90a63d6SPL ID 5b13c06e-52c5-f2c7-e063-6294a90a63d6SPL set ID 93c2fe8b-67d7-4a15-8790-5595e158b3abRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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
N458118075908followed by a unit qualifier and the quantityPackage 58118-0759-08. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 205321
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 50 mg/1 | CapsuleOral | Coupler LLC | 67046-1494 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-758 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-762 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-759 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-760 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-761 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-763 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aurobindo Pharma Limited | 65862-765 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-871 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0760 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0758 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0763 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0761 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0762 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0764 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Clinical Solutions Wholesale, LLC | 58118-0765 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Coupler LLC | 67046-1628 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Coupler LLC | 67046-1680 |