Prescription drug · ANDA
Pregabalin Extended Release (Pregabalin) NDC 50228-462
Pregabalin 82.5 mg/1 · Tablet, Film coated, Extended release · Oral · ScieGen Pharmaceuticals, INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-462-05 | 50228046205 | 500 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-05)Marketed from Sep 14, 2022 | |
| 50228-462-30 | 50228046230 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50228-462-30)Marketed from Sep 14, 2022 |
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 Extended Release
- Generic name (nonproprietary)
- pregabalin
- Active ingredients
- Pregabalin — 82.5 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, INC.NDC labeler code 50228
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215675
- Marketing start
- Listing expires
- DEA schedule
- CV
- Identifiers
- Product ID 50228-462_e90bfe09-9adb-03c0-e053-2a95a90a061eSPL ID e90bfe09-9adb-03c0-e053-2a95a90a061eSPL set ID 1544a657-353c-47f8-96ac-a63fa78373f0RxCUI 1988974, 1988977, 1988980UNII 55JG375S6MUPC 0350228463300, 0350228464055, 0350228464307, 0350228462303, 0350228463058, 0350228462051
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
N450228046205followed by a unit qualifier and the quantityPackage 50228-0462-05. 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 extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy Postherpetic neuralgia Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seizures. Pregabalin extended-release tablets are indicated for the management of: Neuropathic pain associated with diabetic peripheral neuropathy (DPN) ( 1 ) Postherpetic neuralgia (PHN) ( 1 ) Efficacy of pregabalin extended-release tablets has not been established for the management of fibromyalgia or as adjunctive therapy for adult patients with partial onset seiz…
Excerpt only. Read the full label for complete information.
About NDC 50228-462
- What is NDC 50228-462?
- 50228-462 is the product NDC for Pregabalin Extended Release (pregabalin), Pregabalin 82.5 mg/1 tablet, film coated, extended release, listed with the FDA by ScieGen Pharmaceuticals, INC.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Pregabalin Extended Release (Pregabalin).
- What is the active ingredient?
- Pregabalin.
- Who is the labeler?
- ScieGen Pharmaceuticals, INC., NDC labeler code 50228. 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 Extended Release?
- 2 other product NDCs are listed under this name. See all Pregabalin Extended Release NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Pregabalin Extended Release 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 Extended Releasepregabalin | Pregabalin 165 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-463 | 50228-0463-0550228-0463-30 |
| Pregabalin Extended Releasepregabalin | Pregabalin 330 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-464 | 50228-0464-0550228-0464-30 |
Other NDCs under ANDA 215675
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 Extended Releasepregabalin | Pregabalin 165 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-463 |
| Pregabalin Extended Releasepregabalin | Pregabalin 330 mg/1 | Tablet, Film coated, Extended releaseOral | ScieGen Pharmaceuticals, INC. | 50228-464 |