Prescription drug · ANDA
Vigabatrin NDC 69097-964
Vigabatrin 500 mg/mL · Powder, For solution · Oral · Cipla USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69097-964-53 | 69097096453 | 50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKETMarketed from Dec 4, 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)
- Vigabatrin
- Generic name (nonproprietary)
- vigabatrin
- Active ingredients
- Vigabatrin — 500 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Cipla USA, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211592
- Marketing start
- Listing expires
- Identifiers
- Product ID 69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28SPL ID 4cdad60f-7614-47cb-8594-3c0257e55c28SPL set ID 823cc915-0350-4780-85ed-cd1c338e429dRxCUI 250820UNII GR120KRT6K
- 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
N469097096453followed by a unit qualifier and the quantityPackage 69097-0964-53. 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.