Prescription drug · ANDA
Pregabalin NDC 82804-247
Pregabalin 100 mg/1 · Capsule · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82804-247-90 | 82804024790 | 90 CAPSULE in 1 BOTTLE (82804-247-90)Marketed from Oct 30, 2025 |
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 LPNDC labeler code 82804
- 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 82804-247_7d25bec8-b503-4f63-8995-372a6df58c72SPL ID 7d25bec8-b503-4f63-8995-372a6df58c72SPL set ID 7d25bec8-b503-4f63-8995-372a6df58c72RxCUI 483438UNII 55JG375S6MUPC 0382804247905
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
N482804024790followed by a unit qualifier and the quantityPackage 82804-0247-90. 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 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 1month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsule is 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 1month of age and older (1) • Fibromyalgia (1) • Neuropathic pain associated with spinal cord injury (1)…
Excerpt only. Read the full label for complete information.
About NDC 82804-247
- What is NDC 82804-247?
- 82804-247 is the product NDC for Pregabalin, Pregabalin 100 mg/1 capsule, listed with the FDA by Proficient Rx LP. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin.
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- Proficient Rx LP, NDC labeler code 82804. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Pregabalin?
- 507 other product NDCs are listed under this name. See all Pregabalin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4749 | 70518-4749-00 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4743 | 70518-4743-00 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-439 | 29300-0439-19 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-440 | 29300-0440-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-443 | 29300-0443-19 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-444 | 29300-0444-19 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
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 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5071 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6503 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-6504 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | AvPAK | 50268-497 |
| 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 150 mg/1 | CapsuleOral | AvPAK | 50268-501 |
| 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 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2525 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2745 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2762 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-2763 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3345 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-3346 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4024 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-758 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-759 |
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