Prescription drug · NDA
Sabril (Vigabatrin) NDC 67386-111
Vigabatrin 500 mg/1 · Tablet, Film coated · Oral · Lundbeck Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67386-111-01 | 67386011101 | 100 TABLET, FILM COATED in 1 BOTTLE (67386-111-01)Marketed from Aug 21, 2009 |
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)
- Sabril
- Generic name (nonproprietary)
- vigabatrin
- Active ingredients
- Vigabatrin — 500 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Lundbeck Pharmaceuticals LLCNDC labeler code 67386
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020427
- Marketing start
- Listing expires
- Identifiers
- Product ID 67386-111_09c27a1b-5916-4e16-a9a3-924099661be6SPL ID 09c27a1b-5916-4e16-a9a3-924099661be6SPL set ID a5d389d2-d0e1-4395-a2a2-b552808e7f98RxCUI 199521, 860895UNII GR120KRT6KUPC 0367386111011
- 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
N467386011101followed by a unit qualifier and the quantityPackage 67386-0111-01. 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)
SABRIL 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; SABRIL 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) SABRIL 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 benefits o…
Excerpt only. Read the full label for complete information.
About NDC 67386-111
- What is NDC 67386-111?
- 67386-111 is the product NDC for Sabril (vigabatrin), Vigabatrin 500 mg/1 tablet, film coated, listed with the FDA by Lundbeck Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sabril (Vigabatrin).
- What is the active ingredient?
- Vigabatrin.
- Who is the labeler?
- Lundbeck Pharmaceuticals LLC, NDC labeler code 67386. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sabril?
- 1 other product NDC are listed under this name. See all Sabril NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sabril products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sabrilvigabatrin | Vigabatrin 50 mg/mL | Powder, For solutionOral | Lundbeck Pharmaceuticals LLC | 67386-211 | 67386-0211-65 |