NDC codes

FDA NDC Directory
Product NDC (as listed)59651-366Labeler and product segments. Claims need a package NDC.
Product NDC at billing width59651-0366Add 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 NDC11-digit (billing)PackageCopy
59651-366-50596510366505965103665050 PACKET in 1 CARTON (59651-366-50) / 1 POWDER, FOR SOLUTION in 1 PACKET (59651-366-07)Marketed from Sep 29, 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
Generic name (nonproprietary)
vigabatrin
Active ingredients
Vigabatrin — 500 mg/1
Dosage form
Powder, For solution
Route
Oral
Labeler
Aurobindo Pharma LimitedNDC labeler code 59651
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 213899
Marketing start
Listing expires
Identifiers
Product ID 59651-366_7fa314e2-0506-4061-9058-435a3b5df40dSPL ID 7fa314e2-0506-4061-9058-435a3b5df40dSPL set ID c97ce40c-1c5a-479d-9188-5ce03cf7e065RxCUI 250820UNII GR120KRT6KUPC 0359651366073
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

N459651036650 followed by a unit qualifier and the quantity

Package 59651-0366-50. 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 to severa…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 59651-366

What is NDC 59651-366?
59651-366 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 powder, for solution, listed with the FDA by Aurobindo Pharma Limited. 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?
Aurobindo Pharma Limited, NDC labeler code 59651. 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.

Other finished products listed under the same name: strengths, forms and labelers.

Other Vigabatrin NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
vigabatrinVigabatrin 500 mg/1Tablet, Film coatedOralCarnegie Pharmaceuticals LLC80005-16780005-0167-11
vigabatrinVigabatrin 500 mg/10mLPowder, For solutionOralZydus Pharmaceuticals (USA) Inc.70710-149470710-1494-08
vigabatrinVigabatrin 500 mg/10mLPowder, For solutionOralZydus Lifesciences Limited70771-174270771-1742-08
VigabatrinVigabatrin 500 mg/1For solutionOralAmneal Pharmaceuticals NY LLC60219-142560219-1425-05
VigabatrinVigabatrin 500 mg/1TabletOralHikma Pharmaceuticals USA Inc0054-065200054-0652-25
VigabatrinVigabatrin 50 mg/mLFor solutionOralNovadoz Pharmaceuticals LLC72205-09372205-0093-50
VigabatrinVigabatrin 500 mg/1TabletOralEdenbridge Pharmaceuticals LLC.42799-95042799-0950-01
VigabatrinVigabatrin 500 mg/1TabletOralAurobindo Pharma Limited59651-36759651-0367-01
vigabatrinVigabatrin 500 mg/1Tablet, Film coatedOralZydus Pharmaceuticals (USA) Inc.70710-128770710-1287-01
vigabatrinVigabatrin 500 mg/1Tablet, Film coatedOralZydus Lifesciences Limited70771-165470771-1654-01

All 17 Vigabatrin NDCs

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