What is NDC 69097-964?

69097-964 is the product NDC for Vigabatrin, Vigabatrin 500 mg/mL powder, for solution, listed with the FDA by Cipla USA, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Cipla USA, Inc., NDC labeler code 69097. 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 69097-964 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)69097-964Labeler and product segments. Claims need a package NDC.

Product NDC at billing width69097-0964Add 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
69097-964-53	6909709645369097096453	50 PACKET in 1 CARTON (69097-964-53) / 10 mL in 1 PACKETMarketed from Dec 4, 2019

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/mL
Dosage form: Powder, For solution
Route: Oral
Labeler: Cipla USA, Inc.NDC labeler code 69097
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211592
Marketing start: Dec 4, 2019
Listing expires: Dec 31, 2027
Identifiers: Product ID 69097-964_4cdad60f-7614-47cb-8594-3c0257e55c28SPL ID 4cdad60f-7614-47cb-8594-3c0257e55c28SPL set ID 823cc915-0350-4780-85ed-cd1c338e429dRxCUI 250820UNII 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

N469097096453 followed by a unit qualifier and the quantity

Package 69097-0964-53. 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 May 10, 2022. 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 se…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 69097-964

What is NDC 69097-964?: 69097-964 is the product NDC for Vigabatrin, Vigabatrin 500 mg/mL powder, for solution, listed with the FDA by Cipla 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?: Cipla USA, Inc., NDC labeler code 69097. 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