Prescription drug · ANDA
Pregabalin NDC 80425-0030
Pregabalin 75 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0030-1 | 80425003001 | 60 CAPSULE in 1 BOTTLE (80425-0030-1)Marketed from Jul 19, 2019 | |
| 80425-0030-2 | 80425003002 | 90 CAPSULE in 1 BOTTLE (80425-0030-2)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 — 75 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 209357
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 80425-0030_43ccc5cb-7aee-4ee0-e063-6294a90af140SPL ID 43ccc5cb-7aee-4ee0-e063-6294a90af140SPL set ID afc89689-bea9-92ec-e053-2995a90a7f21RxCUI 483450UNII 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
N480425003001followed by a unit qualifier and the quantityPackage 80425-0030-01. 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 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 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 and Oral Solution products. 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 209357
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 | AvPAK | 50268-497 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | AvPAK | 50268-501 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | AvPAK | 50268-498 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | AvPAK | 50268-499 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | AvPAK | 50268-500 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-792 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-750 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-751 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-753 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-845 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-012 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-011 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3346 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-015 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 82804-207 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-013 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3345 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-014 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-016 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Novadoz Pharmaceuticals LLC | 72205-017 |
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