Prescription drug · ANDA
Vigabatrin NDC 49884-358
Vigabatrin 50 mg/mL · Powder, For solution · Oral · Par Health USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49884-358-03 | 4988403580349884035803 | 50 PACKET in 1 CARTON (49884-358-03) / 10 mL in 1 PACKET (49884-358-52)Marketed from Apr 27, 2017 |
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)
- Vigabatrin
- Generic name (nonproprietary)
- vigabatrin
- Active ingredients
- Vigabatrin — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Par Health USA, LLCNDC labeler code 49884
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208218
- Marketing start
- Listing expires
- Identifiers
- Product ID 49884-358_c96e1536-adc6-4318-a40f-7542b80313eeSPL ID c96e1536-adc6-4318-a40f-7542b80313ee
- Pharmacologic class
- Anti-epileptic Agent
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
N449884035803followed by a unit qualifier and the quantityPackage 49884-0358-03. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 49884-358
- What is NDC 49884-358?
- 49884-358 is the product NDC for Vigabatrin, Vigabatrin 50 mg/mL powder, for solution, listed with the FDA by Par Health USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vigabatrin.
- What is the active ingredient?
- Vigabatrin.
- Who is the labeler?
- Par Health USA, LLC, NDC labeler code 49884. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vigabatrin?
- 16 other product NDCs are listed under this name. See all Vigabatrin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vigabatrin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| vigabatrin | Vigabatrin 500 mg/1 | Tablet, Film coatedOral | Carnegie Pharmaceuticals LLC | 80005-167 | 80005-0167-11 |
| vigabatrin | Vigabatrin 500 mg/10mL | Powder, For solutionOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1494 | 70710-1494-08 |
| vigabatrin | Vigabatrin 500 mg/10mL | Powder, For solutionOral | Zydus Lifesciences Limited | 70771-1742 | 70771-1742-08 |
| Vigabatrin | Vigabatrin 500 mg/1 | For solutionOral | Amneal Pharmaceuticals NY LLC | 60219-1425 | 60219-1425-05 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc | 0054-0652 | 00054-0652-25 |
| Vigabatrin | Vigabatrin 50 mg/mL | For solutionOral | Novadoz Pharmaceuticals LLC | 72205-093 | 72205-0093-50 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-950 | 42799-0950-01 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-367 | 59651-0367-01 |
| vigabatrin | Vigabatrin 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1287 | 70710-1287-01 |
| vigabatrin | Vigabatrin 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1654 | 70771-1654-01 |