Prescription drug · ANDA
Pregabalin NDC 43547-513
Pregabalin 300 mg/1 · Capsule · Oral · Solco Healthcare US, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43547-513-09 | 4354705130943547051309 | 90 CAPSULE in 1 BOTTLE (43547-513-09)Marketed from Jun 15, 2020 | |
| 43547-513-50 | 4354705135043547051350 | 500 CAPSULE in 1 BOTTLE (43547-513-50)Marketed from Jun 15, 2020 |
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
- Solco Healthcare US, LLCNDC labeler code 43547
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207883
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 43547-513_a56adbdc-8347-4165-8b9f-f826ff51440cSPL ID a56adbdc-8347-4165-8b9f-f826ff51440cSPL set ID 085db834-3735-40d9-ac67-f9dbb82390c5RxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0343547507091, 0343547513092, 0343547506094, 0343547508098, 0343547509095
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
N443547051309followed by a unit qualifier and the quantityPackage 43547-0513-09. 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 43547-513
- What is NDC 43547-513?
- 43547-513 is the product NDC for Pregabalin, Pregabalin 300 mg/1 capsule, listed with the FDA by Solco Healthcare US, LLC. It has 2 package NDCs, 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?
- Solco Healthcare US, LLC, NDC labeler code 43547. 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?
- 503 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 207883
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 | Solco Healthcare US, LLC | 43547-506 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-507 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-508 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-509 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-510 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-511 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Solco Healthcare US, LLC | 43547-512 |