Vigabatrin NDC 60219-1425

NDC codes

FDA NDC Directory

Product NDC (as listed)60219-1425Labeler and product segments. Claims need a package NDC.

Product NDC at billing width60219-1425Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
60219-1425-5	60219142505	50 FOR SOLUTION in 1 CARTON (60219-1425-5)Marketed from Dec 7, 2023

How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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: For solution
Route: Oral
Labeler: Amneal Pharmaceuticals NY LLC
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 210155
Marketing start: Dec 7, 2023
Listing expires: Dec 31, 2026
Identifiers: Product ID 60219-1425_3bf642d5-5597-4668-a4ab-d240699a395eSPL ID 3bf642d5-5597-4668-a4ab-d240699a395eSPL set ID 9791494f-492b-487a-8211-7747fb57923eRxCUI 250820UNII GR120KRT6KUPC 0360219142558, 0360219142510
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

N460219142505 followed by a unit qualifier and the quantity

Package 60219-1425-05. 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 Feb 28, 2023. 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 to …

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 210155

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 210155
Product	Strength	Form · route	Labeler	Product NDC
Vigabatrin	Vigabatrin 500 mg/1	For solutionOral	Amneal Pharmaceuticals NY LLC	69238-1425