Prescription drug · ANDA
Vigabatrin NDC 69238-1425
Vigabatrin 500 mg/1 · For solution · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1425-5 | 69238142505 | 50 FOR SOLUTION in 1 CARTON (69238-1425-5)Marketed from Mar 19, 2018 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 500 mg/1
- Dosage form
- For solution
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 210155
- Marketing start
- Listing expires
- Identifiers
- Product ID 69238-1425_cb7e94d1-fc6e-4b9e-a58d-575d7a8a06a8SPL ID cb7e94d1-fc6e-4b9e-a58d-575d7a8a06a8SPL set ID 5b8fb137-848b-45fd-9107-a6db5a675360RxCUI 250820UNII GR120KRT6KUPC 0369238142518
- 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
N469238142505followed by a unit qualifier and the quantityPackage 69238-1425-05. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Vigabatrin for oral solution is indicated for the treatment of: Refractory Complex Partial Seizures as adjunctive therapy in patients 2 years of age and older who have responded inadequately to several alternative treatments; vigabatrin for oral solution is not indicated as a first line agent ( 1.1 ) Infantile Spasms - monotherapy in infants 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss ( 1.2 ) 1.1 Refractory Complex Partial Seizures (CPS) Vigabatrin for oral solution is indicated as adjunctive therapy for adults and pediatric patients 2 years of age and older with refractory complex partial seizures who have inadequately responded to se…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 210155
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 |
|---|---|---|---|---|
| Vigabatrin | Vigabatrin 500 mg/1 | For solutionOral | Amneal Pharmaceuticals NY LLC | 60219-1425 |