Prescription drug · ANDA
Pregabalin NDC 71205-338
Pregabalin 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-338-30 | 71205033830 | 30 CAPSULE in 1 CARTON (71205-338-30)Marketed from Oct 1, 2019 | |
| 71205-338-60 | 71205033860 | 60 CAPSULE in 1 CARTON (71205-338-60)Marketed from Oct 1, 2019 | |
| 71205-338-90 | 71205033890 | 90 CAPSULE in 1 CARTON (71205-338-90)Marketed from Oct 1, 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 — 100 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Proficient Rx LP
- 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 71205-338_4624c58f-8f77-48fa-be0f-fca4010cc8aeSPL ID 4624c58f-8f77-48fa-be0f-fca4010cc8aeSPL set ID 4624c58f-8f77-48fa-be0f-fca4010cc8aeRxCUI 483438UNII 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
N471205033830followed by a unit qualifier and the quantityPackage 71205-0338-30. 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 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. Pregabalin capsules are indicated for: • Neuropathic pain associated with diabetic peripheral neuropathy (DPN) (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 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 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Major Pharmaceuticals | 0904-7001 |
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