Prescription drug · ANDA
Vigabatrin NDC 67877-674
Vigabatrin 50 mg/mL · Powder, For solution · Oral · Ascend Laboratories, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67877-674-63 | 67877067463 | 50 PACKET in 1 CARTON (67877-674-63) / 10 mL in 1 PACKETMarketed from Dec 3, 2020 |
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 — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Ascend Laboratories, LLCNDC labeler code 67877
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213375
- Marketing start
- Listing expires
- Identifiers
- Product ID 67877-674_e55f8225-aa06-4e46-81d2-757233b95585SPL ID e55f8225-aa06-4e46-81d2-757233b95585SPL set ID ee835fb6-2b2b-40c4-b6d7-0ad0e790cda8RxCUI 250820UNII GR120KRT6KUPC 0367877674636
- 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
N467877067463followed by a unit qualifier and the quantityPackage 67877-0674-63. 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)
1. INDICATIONS AND USAGE 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 inad…
Excerpt only. Read the full label for complete information.
About NDC 67877-674
- What is NDC 67877-674?
- 67877-674 is the product NDC for Vigabatrin, Vigabatrin 50 mg/mL powder, for solution, listed with the FDA by Ascend Laboratories, 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?
- Ascend Laboratories, LLC, NDC labeler code 67877. 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?
- 17 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/1 | Tablet, Film coatedOral | Carnegie Pharmaceuticals LLC | 80005-167 | 80005-0167-11 |
| 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 |