Prescription drug · ANDA
Pregabalin NDC 62135-445
Pregabalin 75 mg/1 · Capsule · Oral · Chartwell RX, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62135-445-90 | 62135044590 | 90 CAPSULE in 1 BOTTLE (62135-445-90)Marketed from Jul 25, 2025 |
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)
- Pregabalin
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Chartwell RX, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212865
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 62135-445_4361bef4-846b-7589-e063-6294a90a9292SPL ID 4361bef4-846b-7589-e063-6294a90a9292SPL set ID 13d03119-e49b-482e-b5f9-d40dc3f4862eRxCUI 483438, 483440, 483448, 483450UNII 55JG375S6MUPC 0362135447908, 0362135445904, 0362135444907, 0362135446901
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
N462135044590followed by a unit qualifier and the quantityPackage 62135-0445-90. 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
Current FDA label (SPL), effective .
Indications (excerpt from the label)
Pregabalin 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 Pregabalin Capsules are 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 ANDA 212865
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 | Chartwell RX, LLC | 62135-444 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-446 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Chartwell RX, LLC | 62135-447 |