NDC codes

FDA NDC Directory
Product NDC (as listed)42799-950Labeler and product segments. Claims need a package NDC.
Product NDC at billing width42799-0950Add 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
42799-950-014279909500142799095001100 TABLET in 1 BOTTLE (42799-950-01)Marketed from Jun 29, 2022

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
Route
Oral
Labeler
Edenbridge Pharmaceuticals LLC.NDC labeler code 42799
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 215109
Marketing start
Listing expires
Identifiers
Product ID 42799-950_f96ecebb-fe76-4332-85ec-60303d6c8c99SPL ID f96ecebb-fe76-4332-85ec-60303d6c8c99SPL set ID 93ba3894-fd97-4432-9f2d-e7050371e91fRxCUI 199521UNII GR120KRT6K
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

N442799095001 followed by a unit qualifier and the quantity

Package 42799-0950-01. 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 treat…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 42799-950

What is NDC 42799-950?
42799-950 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 tablet, listed with the FDA by Edenbridge 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?
Edenbridge Pharmaceuticals LLC., NDC labeler code 42799. 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/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
VigabatrinVigabatrin 500 mg/1Powder, For solutionOralAurobindo Pharma Limited59651-36659651-0366-50

All 17 Vigabatrin NDCs

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