Prescription drug · ANDA
Pregabalin NDC 62332-126
Pregabalin 300 mg/1 · Capsule · Oral · Alembic Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 62332-126-10 | 62332012610 | 100 CAPSULE in 1 CARTON (62332-126-10)Marketed from Jul 19, 2019 | |
| 62332-126-30 | 62332012630 | 30 CAPSULE in 1 BOTTLE (62332-126-30)Marketed from Jul 19, 2019 | |
| 62332-126-71 | 62332012671 | 500 CAPSULE in 1 BOTTLE (62332-126-71)Marketed from Jul 19, 2019 | |
| 62332-126-90 | 62332012690 | 90 CAPSULE in 1 BOTTLE (62332-126-90)Marketed from Jul 19, 2019 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Alembic Pharmaceuticals Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 203459
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 62332-126_1e87ec6d-6f2d-400f-bf21-08fcce28bb6cSPL ID 1e87ec6d-6f2d-400f-bf21-08fcce28bb6cSPL set ID cf7b4b67-b017-47ac-af3f-bde5bd07bb0cRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0362332124305, 0362332122301, 0362332125302, 0362332126309, 0362332123308
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
N462332012610followed by a unit qualifier and the quantityPackage 62332-0126-10. 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 capsule 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 capsule is 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 203459
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 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-122 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-119 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-120 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-121 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-123 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-124 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Alembic Pharmaceuticals Inc. | 62332-125 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-119 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-123 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-120 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-121 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-122 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-124 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-125 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Alembic Pharmaceuticals Limited | 46708-126 |