What is NDC 80789-003?

80789-003 is the product NDC for Vigafyde (vigabatrin), Vigabatrin 100 mg/mL solution, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Upsher-Smith Laboratories, LLC, NDC labeler code 80789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Vigafyde?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Vigafyde NDC 80789-003 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)80789-003Labeler and product segments. Claims need a package NDC.

Product NDC at billing width80789-0003Add 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
80789-003-15	8078900031580789000315	1 BOTTLE in 1 CARTON (80789-003-15) / 150 mL in 1 BOTTLEMarketed from Aug 26, 2024

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): Vigafyde
Generic name (nonproprietary): vigabatrin
Active ingredients: Vigabatrin — 100 mg/mL
Dosage form: Solution
Route: Oral
Labeler: Upsher-Smith Laboratories, LLCNDC labeler code 80789
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 217684
Marketing start: Jun 18, 2024
Listing expires: Dec 31, 2027
Identifiers: Product ID 80789-003_43aeb38a-b4ee-47ed-8239-c488b074f1c9SPL ID 43aeb38a-b4ee-47ed-8239-c488b074f1c9SPL set ID 8d3d6316-33ab-41e8-9485-4495c218be56RxCUI 2685217, 2685223UNII 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

N480789000315 followed by a unit qualifier and the quantity

Package 80789-0003-15. 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 Nov 1, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

VIGAFYDE is indicated as monotherapy for the treatment of i nfantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss. ( 1 ) VIGAFYDE is indicated as monotherapy for the treatment of infantile spasms in pediatric patients 1 month to 2 years of age for whom the potential benefits outweigh the potential risk of vision loss [see Warnings and Precautions ( 5.1 )].

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 80789-003

What is NDC 80789-003?: 80789-003 is the product NDC for Vigafyde (vigabatrin), Vigabatrin 100 mg/mL solution, listed with the FDA by Upsher-Smith Laboratories, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Vigafyde (Vigabatrin).
What is the active ingredient?: Vigabatrin.
Who is the labeler?: Upsher-Smith Laboratories, LLC, NDC labeler code 80789. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Vigafyde?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Vigafyde (Vigabatrin) NDC 80789-003