What is NDC 0054-0652?

0054-0652 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc. It has 1 package NDC, shown above in 10- and 11-digit form.

Hikma Pharmaceuticals USA Inc, NDC labeler code 0054. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vigabatrin NDC 0054-0652 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0054-0652Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00054-0652Add 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
0054-0652-25	00054065225	100 TABLET in 1 BOTTLE (0054-0652-25)Marketed from Sep 9, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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: Hikma Pharmaceuticals USA IncNDC labeler code 0054
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 213104
Marketing start: Sep 9, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 0054-0652_f575e137-5300-4e13-a40e-5573f6c8a066SPL ID f575e137-5300-4e13-a40e-5573f6c8a066SPL set ID 5ed8d293-b7d8-4c66-9c31-8075e6f99092RxCUI 199521UNII GR120KRT6KUPC 0300540652258
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

N400054065225 followed by a unit qualifier and the quantity

Package 00054-0652-25. 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 Aug 11, 2022. 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 0054-0652

What is NDC 0054-0652?: 0054-0652 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 tablet, listed with the FDA by Hikma Pharmaceuticals USA Inc. 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?: Hikma Pharmaceuticals USA Inc, NDC labeler code 0054. 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.

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

Other Vigabatrin NDCs
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 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
Vigabatrin	Vigabatrin 500 mg/1	Powder, For solutionOral	Aurobindo Pharma Limited	59651-366	59651-0366-50

All 18 Vigabatrin NDCs