Prescription drug · ANDA
vigabatrin NDC 80005-167
Vigabatrin 500 mg/1 · Tablet, Film coated · Oral · Carnegie Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80005-167-11 | 8000501671180005016711 | 1 BOTTLE in 1 CARTON (80005-167-11) / 100 TABLET, FILM COATED in 1 BOTTLEMarketed from Feb 18, 2026 |
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
- Labeler
- Carnegie Pharmaceuticals LLCNDC labeler code 80005
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215519
- Marketing start
- Listing expires
- Identifiers
- Product ID 80005-167_533a7f8e-4ac6-4688-9ea0-a90626c86ab8SPL ID 533a7f8e-4ac6-4688-9ea0-a90626c86ab8SPL set ID 8406bd5a-8887-4579-a11e-5ab449c58963RxCUI 199521UNII GR120KRT6KUPC 0380005167114
- 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
N480005016711followed by a unit qualifier and the quantityPackage 80005-0167-11. 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)
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 treatments…
Excerpt only. Read the full label for complete information.
About NDC 80005-167
- What is NDC 80005-167?
- 80005-167 is the product NDC for vigabatrin, Vigabatrin 500 mg/1 tablet, film coated, listed with the FDA by Carnegie Pharmaceuticals LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- vigabatrin.
- What is the active ingredient?
- Vigabatrin.
- Who is the labeler?
- Carnegie Pharmaceuticals LLC, NDC labeler code 80005. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for vigabatrin?
- 16 other product NDCs are listed under this name. See all vigabatrin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other vigabatrin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| vigabatrin | Vigabatrin 500 mg/10mL | Powder, For solutionOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1494 | 70710-1494-08 |
| vigabatrin | Vigabatrin 500 mg/10mL | Powder, For solutionOral | Zydus Lifesciences Limited | 70771-1742 | 70771-1742-08 |
| Vigabatrin | Vigabatrin 500 mg/1 | For solutionOral | Amneal Pharmaceuticals NY LLC | 60219-1425 | 60219-1425-05 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Hikma Pharmaceuticals USA Inc | 0054-0652 | 00054-0652-25 |
| Vigabatrin | Vigabatrin 50 mg/mL | For solutionOral | Novadoz Pharmaceuticals LLC | 72205-093 | 72205-0093-50 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Edenbridge Pharmaceuticals LLC. | 42799-950 | 42799-0950-01 |
| Vigabatrin | Vigabatrin 500 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-367 | 59651-0367-01 |
| vigabatrin | Vigabatrin 500 mg/1 | Tablet, Film coatedOral | Zydus Pharmaceuticals (USA) Inc. | 70710-1287 | 70710-1287-01 |
| vigabatrin | Vigabatrin 500 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 70771-1654 | 70771-1654-01 |
| Vigabatrin | Vigabatrin 500 mg/1 | Powder, For solutionOral | Aurobindo Pharma Limited | 59651-366 | 59651-0366-50 |