Prescription drug · ANDA
Pregabalin NDC 82968-008
Pregabalin 75 mg/1 · Capsule · Oral · FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82968-008-02 | 82968000802 | 90 CAPSULE in 1 BOTTLE (82968-008-02)Marketed from Feb 24, 2026 | |
| 82968-008-04 | 82968000804 | 100 BLISTER PACK in 1 CARTON (82968-008-04) / 1 CAPSULE in 1 BLISTER PACKMarketed from Feb 24, 2026 |
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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 218529
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 82968-008_4c41b54b-827a-1d04-e063-6394a90a55eaSPL ID 4c41b54b-827a-1d04-e063-6394a90a55eaSPL set ID 9bdea600-b561-4049-aa1c-3867b62fc1d3RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0382968006011, 0382968013019, 0382968009029, 0382968008022, 0382968010018
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
N482968000802followed by a unit qualifier and the quantityPackage 82968-0008-02. 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 218529
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 | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-007 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-006 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-011 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-009 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-010 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-012 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | FOURRTS (INDIA) LABORATORIES PRIVATE LIMITED | 82968-013 |