Prescription drug · ANDA
vigabatrin for oral solution (Vigabatrin) NDC 31722-009
Vigabatrin 50 mg/mL · Powder, For solution · Oral · Camber Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 31722-009-50 | 3172200095031722000950 | 50 PACKET in 1 CARTON (31722-009-50) / 10 mL in 1 PACKETMarketed from Jan 26, 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 for oral solution
- Generic name (nonproprietary)
- vigabatrin
- Active ingredients
- Vigabatrin — 50 mg/mL
- Dosage form
- Powder, For solution
- Route
- Oral
- Labeler
- Camber Pharmaceuticals, Inc.NDC labeler code 31722
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 213519
- Marketing start
- Listing expires
- Identifiers
- Product ID 31722-009_16ae8082-260c-b789-e063-6294a90ab6e8SPL ID 16ae8082-260c-b789-e063-6294a90ab6e8SPL set ID bda491b6-47ba-400b-9816-b6d15c6e2683RxCUI 250820UNII GR120KRT6KUPC 0331722009508
- 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
N431722000950followed by a unit qualifier and the quantityPackage 31722-0009-50. 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 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 inadequately responded t…
Excerpt only. Read the full label for complete information.
About NDC 31722-009
- What is NDC 31722-009?
- 31722-009 is the product NDC for vigabatrin for oral solution (vigabatrin), Vigabatrin 50 mg/mL powder, for solution, listed with the FDA by Camber Pharmaceuticals, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- vigabatrin for oral solution (Vigabatrin).
- What is the active ingredient?
- Vigabatrin.
- Who is the labeler?
- Camber Pharmaceuticals, Inc., NDC labeler code 31722. 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 for oral solution?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.