Prescription drug · ANDA
Pregabalin NDC 64980-410
Pregabalin 25 mg/1 · Capsule · Oral · Rising Pharma Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 64980-410-01 | 64980041001 | 10 BLISTER PACK in 1 CARTON (64980-410-01) / 10 CAPSULE in 1 BLISTER PACKMarketed from Jul 19, 2019 | |
| 64980-410-09 | 64980041009 | 90 CAPSULE in 1 BOTTLE (64980-410-09)Marketed from Jul 19, 2019 | |
| 64980-410-10 | 64980041010 | 1000 CAPSULE in 1 BOTTLE (64980-410-10)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 — 25 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Rising Pharma Holdings, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210432
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 64980-410_ed8357e8-6f9d-4b09-b3f0-48417fe7f481SPL ID ed8357e8-6f9d-4b09-b3f0-48417fe7f481SPL set ID dbebfa61-0685-41b4-8364-00b8d8b73714RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0364980413107, 0364980411103, 0364980415101, 0364980412100, 0364980416108, 0364980414104, 0364980410106, 0364980417105
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
N464980041001followed by a unit qualifier and the quantityPackage 64980-0410-01. 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 210432
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 | American Health Packaging | 60687-484 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | American Health Packaging | 60687-495 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | American Health Packaging | 60687-506 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | American Health Packaging | 60687-517 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8097 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-8098 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-338 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1459 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1476 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1475 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Cardinal Health 107, LLC | 55154-4308 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6793 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1505 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Advanced Rx of Tennessee, LLC | 80425-0027 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6991 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-1555 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4569 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 72162-2304 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-6992 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7000 |
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