Prescription drug · ANDA
Pregabalin NDC 51407-581
Pregabalin 300 mg/1 · Capsule · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-581-90 | 51407058190 | 90 CAPSULE in 1 BOTTLE (51407-581-90)Marketed from Jul 3, 2024 |
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 — 300 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- Golden State Medical Supply, Inc.NDC labeler code 51407
- 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 51407-581_4602216f-16b6-05b7-e063-6294a90a79bfSPL ID 4602216f-16b6-05b7-e063-6294a90a79bfSPL set ID 1ef735e8-467e-ed0d-e063-6294a90a210eRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 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
N451407058190followed by a unit qualifier and the quantityPackage 51407-0581-90. 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 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 1 month of age and older • Management of fibromyalgia • Management of neuropathic pain associated with spinal cord injury Pregabalin capsules are 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 1 month 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 51407-581
- What is NDC 51407-581?
- 51407-581 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Golden State Medical Supply, Inc.. 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?
- Golden State Medical Supply, Inc., NDC labeler code 51407. 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 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 75 mg/1 | CapsuleOral | A-S Medication Solutions | 50090-5038 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-350 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-351 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-352 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-353 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-354 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-355 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-356 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-357 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-645 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-646 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-647 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-648 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-649 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-650 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-651 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-652 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-574 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-575 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-576 |
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