Prescription drug · ANDA
Pregablin NDC 33342-171
Pregabalin 225 mg/1 · Capsule · Oral · Macleods Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 33342-171-10 | 33342017110 | 90 CAPSULE in 1 BOTTLE (33342-171-10)Marketed from Nov 13, 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)
- Pregablin
- Generic name (nonproprietary)
- pregablin
- Active ingredients
- Pregabalin — 225 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 205924
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 33342-171_cb84edec-54d3-4100-99d9-b513cc6cbf1eSPL ID cb84edec-54d3-4100-99d9-b513cc6cbf1eSPL set ID a3a94949-3060-4057-9b29-e06a808cbd76RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0333342168108, 0333342166104, 0333342165107, 0333342172105, 0333342169105, 0333342167101, 0333342170101
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
N433342017110followed by a unit qualifier and the quantityPackage 33342-0171-10. 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 capsules are 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 205924
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 |
|---|---|---|---|---|
| Pregablin | Pregabalin 100 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-168 |
| Pregablin | Pregabalin 25 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-165 |
| Pregablin | Pregabalin 50 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-166 |
| Pregablin | Pregabalin 75 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-167 |
| Pregablin | Pregabalin 150 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-169 |
| Pregablin | Pregabalin 200 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-170 |
| Pregablin | Pregabalin 300 mg/1 | CapsuleOral | Macleods Pharmaceuticals Limited | 33342-172 |