Prescription drug · ANDA
Vigadrone (Vigabatrin) NDC 0245-6001
Vigabatrin 500 mg/1 · Tablet · Oral · Upsher-Smith Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0245-6001-11 | 0024560011100245600111 | 1 BOTTLE in 1 CARTON (0245-6001-11) / 100 TABLET in 1 BOTTLEMarketed from Jun 30, 2023 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
- Vigadrone
- Generic name (nonproprietary)
- vigabatrin
- Active ingredients
- Vigabatrin — 500 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Upsher-Smith Laboratories, LLCNDC labeler code 0245
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214749
- Marketing start
- Listing expires
- Identifiers
- Product ID 0245-6001_2734e899-4ddc-836c-e063-6294a90a128fSPL ID 2734e899-4ddc-836c-e063-6294a90a128fSPL set ID 01f7f049-78c2-47c2-a66e-ec662ba48a98RxCUI 199521, 2642353UNII 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
N400245600111followed by a unit qualifier and the quantityPackage 00245-6001-11. 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)
VIGADRONE 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; VIGADRONE 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) VIGADRONE 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 several alternative treatments and for whom the potential b…
Excerpt only. Read the full label for complete information.
About NDC 0245-6001
- What is NDC 0245-6001?
- 0245-6001 is the product NDC for Vigadrone (vigabatrin), Vigabatrin 500 mg/1 tablet, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Vigadrone (Vigabatrin).
- What is the active ingredient?
- Vigabatrin.
- Who is the labeler?
- Upsher-Smith Laboratories, LLC, NDC labeler code 0245. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Vigadrone?
- 1 other product NDC are listed under this name. See all Vigadrone NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Vigadrone products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Vigadronevigabatrin | Vigabatrin 50 mg/mL | Powder, For solutionOral | Upsher-Smith Laboratories, LLC | 0245-0556 | 00245-0556-50 |