Prescription drug · ANDA
Pregabalin NDC 80425-0025
Pregabalin 50 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0025-1 | 80425002501 | 60 CAPSULE in 1 BOTTLE (80425-0025-1)Marketed from Jul 19, 2019 | |
| 80425-0025-2 | 80425002502 | 90 CAPSULE in 1 BOTTLE (80425-0025-2)Marketed from Jul 19, 2019 | |
| 80425-0025-3 | 80425002503 | 30 CAPSULE in 1 BOTTLE (80425-0025-3)Marketed from Jul 19, 2019 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 50 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209743
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 80425-0025_2a988314-6237-2d61-e063-6294a90a3e84SPL ID 2a988314-6237-2d61-e063-6294a90a3e84SPL set ID af739a0d-a3cd-754f-e053-2a95a90ad655RxCUI 483448UNII 55JG375S6M
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
N480425002501followed by a unit qualifier and the quantityPackage 80425-0025-01. 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)
1. Indications and Usage Section 1 INDICATIONS AND USAGE 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 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury Pediatric use information is approved for Pfizer’s LYRICA (pregabalin) Capsules. However, due to Pfizer’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 209743
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 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-816 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Direct_Rx | 72189-033 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Direct_Rx | 72189-115 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1310 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1314 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1311 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1312 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1313 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1315 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1316 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 69238-1317 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1312 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1310 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1311 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1316 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1313 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Direct_Rx | 72189-164 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1314 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1315 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Amneal Pharmaceuticals NY LLC | 60219-1317 |
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