Prescription drug · ANDA
Pregabalin NDC 13668-360
Pregabalin 75 mg/1 · Capsule · Oral · Torrent Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 13668-360-01 | 13668036001 | 100 CAPSULE in 1 BOTTLE (13668-360-01)Marketed from May 19, 2025 | |
| 13668-360-05 | 13668036005 | 500 CAPSULE in 1 BOTTLE (13668-360-05)Marketed from May 19, 2025 | |
| 13668-360-30 | 13668036030 | 30 CAPSULE in 1 BOTTLE (13668-360-30)Marketed from May 19, 2025 | |
| 13668-360-90 | 13668036090 | 90 CAPSULE in 1 BOTTLE (13668-360-90)Marketed from May 19, 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
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206942
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 13668-360_f28a120a-aea5-45b9-84f7-06f48f41bc03SPL ID f28a120a-aea5-45b9-84f7-06f48f41bc03SPL set ID a062e78a-16ff-4d83-b700-0badb7d812d5RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0313668361308, 0313668359305, 0313668365306, 0313668358308, 0313668363302, 0313668364309, 0313668362305, 0313668360301
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
N413668036001followed by a unit qualifier and the quantityPackage 13668-0360-01. 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 206942
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 25 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-358 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-362 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-359 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-361 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-365 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-363 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Torrent Pharmaceuticals Limited | 13668-364 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4579 |