What is NDC 62559-385?

62559-385 is the product NDC for Veregen (sinecatechins), Sinecatechins 150 mg/g ointment, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Veregen?

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.

Veregen NDC 62559-385 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)62559-385Labeler and product segments. Claims need a package NDC.

Product NDC at billing width62559-0385Add 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
62559-385-26	62559038526	6 CARTON in 1 CARTON (62559-385-26) / 1 TUBE in 1 CARTON (62559-385-02) / 2 g in 1 TUBEMarketed from Nov 10, 2022 · Sample package
62559-385-30	62559038530	1 TUBE in 1 CARTON (62559-385-30) / 30 g in 1 TUBEMarketed from Nov 10, 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): Veregen
Generic name (nonproprietary): sinecatechins
Active ingredients: Sinecatechins — 150 mg/g
Dosage form: Ointment
Route: Topical
Labeler: ANI Pharmaceuticals, Inc.NDC labeler code 62559
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 021902
Marketing start: Nov 10, 2022
Listing expires: Dec 31, 2026
Identifiers: Product ID 62559-385_64ad4fa5-8381-41db-8d9b-62fa44843180SPL ID 64ad4fa5-8381-41db-8d9b-62fa44843180SPL set ID f0fc1e21-e3cf-4bce-860c-307f670b192eRxCUI 753350, 795918UNII T432289GYZUPC 0362559385305

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. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N462559038526 followed by a unit qualifier and the quantity

Package 62559-0385-26. 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 10, 2022.

Indications (excerpt from the label)

Veregen is a topical ointment indicated for the treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older (1.1) . Limitations of Use Safety and effectiveness of Veregen have not been established in immunosuppressed patients, in treatment of external genital and perianal warts beyond 16-weeks, or for multiple treatment courses (1.2) . 1.1 Indication Veregen is indicated for the topical treatment of external genital and perianal warts (Condylomata acuminata) in immunocompetent patients 18 years and older. 1.2 Limitations of Use The safety and effectiveness of Veregen have not been established for treatment beyond 16-weeks or for mul…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 62559-385

What is NDC 62559-385?: 62559-385 is the product NDC for Veregen (sinecatechins), Sinecatechins 150 mg/g ointment, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Veregen (Sinecatechins).
What is the active ingredient?: Sinecatechins.
Who is the labeler?: ANI Pharmaceuticals, Inc., NDC labeler code 62559. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Veregen?: 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.

Veregen (Sinecatechins) NDC 62559-385