Prescription drug · ANDA
Pregabalin NDC 80425-0028
Pregabalin 75 mg/1 · Capsule · Oral · Advanced Rx of Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80425-0028-1 | 80425002801 | 60 CAPSULE in 1 BOTTLE (80425-0028-1)Marketed from Jul 19, 2019 | |
| 80425-0028-2 | 80425002802 | 90 CAPSULE in 1 BOTTLE (80425-0028-2)Marketed from Jul 19, 2019 | |
| 80425-0028-3 | 80425002803 | 30 CAPSULE in 1 BOTTLE (80425-0028-3)Marketed from Apr 4, 2023 |
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 208677
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 80425-0028_2a987953-08d0-1c4c-e063-6394a90a5a82SPL ID 2a987953-08d0-1c4c-e063-6394a90a5a82SPL set ID afc8c76e-9b21-7ddb-e053-2a95a90ad736RxCUI 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
N480425002801followed by a unit qualifier and the quantityPackage 80425-0028-01. 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)
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 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 208677
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 | Aphena Pharma Solutions - Tennessee, LLC | 71610-808 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0433 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-304 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Advanced Rx Pharmacy of Tennessee, LLC | 80425-0177 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-870 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Proficient Rx LP | 71205-869 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Proficient Rx LP | 71205-874 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-871 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-872 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-873 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Proficient Rx LP | 71205-876 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Proficient Rx LP | 71205-323 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Proficient Rx LP | 71205-875 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 71335-3118 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-799 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-800 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-820 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Proficient Rx LP | 71205-396 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Proficient Rx LP | 71205-677 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Preferred Pharmaceuticals, Inc. | 68788-7522 |
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