Prescription drug · ANDA
Vigabatrin NDC 43598-651
Vigabatrin 500 mg/1 · Tablet, Film coated · Oral · Dr. Reddys Laboratories Inc.,
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43598-651-01 | 43598065101 | 100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)Marketed from Feb 1, 2021 |
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/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211539
- Marketing start
- Listing expires
- Identifiers
- Product ID 43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74SPL ID f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74SPL set ID 0afdc84c-f8ec-330a-31c9-fac4ed256931RxCUI 199521UNII GR120KRT6KUPC 0343598651019
- 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
N443598065101followed by a unit qualifier and the quantityPackage 43598-0651-01. 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 tablets are 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 tablets are 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 tablets are 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 several alternative treatment…
Excerpt only. Read the full label for complete information.