Prescription drug · ANDA
Pregabalin NDC 50228-355
Pregabalin 200 mg/1 · Capsule · Oral · ScieGen Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50228-355-05 | 50228035505 | 500 CAPSULE in 1 BOTTLE (50228-355-05)Marketed from Jul 19, 2019 | |
| 50228-355-30 | 50228035530 | 30 CAPSULE in 1 BOTTLE (50228-355-30)Marketed from Jul 19, 2019 | |
| 50228-355-90 | 50228035590 | 90 CAPSULE in 1 BOTTLE (50228-355-90)Marketed from Jul 19, 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 — 200 mg/1
- Dosage form
- Capsule
- Route
- Oral
- Labeler
- ScieGen Pharmaceuticals, IncNDC labeler code 50228
- 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 50228-355_955253a7-d80a-44ef-83c4-74b33ee6a622SPL ID 955253a7-d80a-44ef-83c4-74b33ee6a622SPL set ID 33ef1a3b-554f-4a51-afdb-92a019e8c16cRxCUI 483438, 483440, 483442, 483444, 483446, 483448, 483450, 577127UNII 55JG375S6MUPC 0350228356053, 0350228354301, 0350228355056, 0350228357050, 0350228352901, 0350228357906, 0350228356909, 0350228350907, 0350228354103, 0350228350105, 0350228353908, 0350228351904, 0350228354905, 0350228355902, 0350228352307, 0350228352109, 0350228353106, 0350228351102
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
N450228035505followed by a unit qualifier and the quantityPackage 50228-0355-05. 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 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 50228-355
- What is NDC 50228-355?
- 50228-355 is the product NDC for Pregabalin, Pregabalin 200 mg/1 capsule, listed with the FDA by ScieGen Pharmaceuticals, Inc. It has 3 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?
- 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?
- 509 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 75 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-441 | 29300-0441-19 |
| 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 300 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-446 | 29300-0446-19 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4715 | 70518-4715-00 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | REMEDYREPACK INC. | 70518-4716 | 70518-4716-00 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-445 | 29300-0445-19 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Unichem Pharmaceuticals (USA), Inc. | 29300-442 | 29300-0442-19 |
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 200 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-329 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-580 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-591 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Golden State Medical Supply, Inc. | 51407-581 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-330 |
| Pregabalin | Pregabalin 300 mg/1 | CapsuleOral | Westminster Pharmaceuticals, LLC | 69367-331 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-827 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-485 |
| Pregabalin | Pregabalin 225 mg/1 | CapsuleOral | Direct Rx | 72189-328 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | St. Mary's Medical Park Pharmacy | 60760-507 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-719 |
| Pregabalin | Pregabalin 200 mg/1 | CapsuleOral | Quality Care Products, LLC | 55700-964 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8195 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8196 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | Proficient Rx LP | 71205-556 |
| Pregabalin | Pregabalin 25 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-645 |
| Pregabalin | Pregabalin 100 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8197 |
| Pregabalin | Pregabalin 50 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-646 |
| Pregabalin | Pregabalin 150 mg/1 | CapsuleOral | Bryant Ranch Prepack | 63629-8198 |
| Pregabalin | Pregabalin 75 mg/1 | CapsuleOral | ScieGen Pharmaceuticals, Inc | 50228-647 |
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