What is NDC 43598-651?

43598-651 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 tablet, film coated, listed with the FDA by Dr. Reddys Laboratories Inc.,. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddys Laboratories Inc.,, NDC labeler code 43598. 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.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vigabatrin NDC 43598-651 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)43598-651Labeler and product segments. Claims need a package NDC.

Product NDC at billing width43598-0651Add 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
43598-651-01	4359806510143598065101	100 TABLET, FILM COATED in 1 BOTTLE (43598-651-01)Marketed from Feb 1, 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: Tablet, Film coated
Route: Oral
Labeler: Dr. Reddys Laboratories Inc.,NDC labeler code 43598
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211539
Marketing start: Feb 1, 2021
Listing expires: Dec 31, 2027
Identifiers: Product ID 43598-651_f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74SPL ID f9d29bec-f73b-7dc9-5f1b-7857dc0fdb74SPL set ID 0afdc84c-f8ec-330a-31c9-fac4ed256931RxCUI 199521UNII GR120KRT6KUPC 0343598651019
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

N443598065101 followed by a unit qualifier and the quantity

Package 43598-0651-01. 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 Mar 17, 2020. 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 treatment…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 43598-651

What is NDC 43598-651?: 43598-651 is the product NDC for Vigabatrin, Vigabatrin 500 mg/1 tablet, film coated, listed with the FDA by Dr. Reddys Laboratories 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?: Dr. Reddys Laboratories Inc.,, NDC labeler code 43598. 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
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 500 mg/1	TabletOral	Hikma Pharmaceuticals USA Inc	0054-0652	00054-0652-25
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

All 17 Vigabatrin NDCs