What is NDC 0574-0611?

0574-0611 is the product NDC for Podofilox, Podofilox 5 mg/mL solution, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.

Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Podofilox?

1 other product NDC are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Podofilox NDC 0574-0611 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0611Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0611Add 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
0574-0611-05	00574061105	1 BOTTLE, GLASS in 1 CARTON (0574-0611-05) / 3.5 mL in 1 BOTTLE, GLASSMarketed from Jan 29, 2002

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): Podofilox
Generic name (nonproprietary): podofilox
Active ingredients: Podofilox — 5 mg/mL
Dosage form: Solution
Route: Topical
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 075600
Marketing start: Jan 29, 2002
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Mitosis (Physiologic effect)
Identifiers: Product ID 0574-0611_e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76daSPL ID e75d3f9f-dd11-4c3e-9e6e-3d9af2cd76daSPL set ID 6af07697-5203-43e0-ba35-83683af851c3RxCUI 582926UNII L36H50F353

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

N400574061105 followed by a unit qualifier and the quantity

Package 00574-0611-05. 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 Feb 28, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Podofilox Topical Solution 0.5% is indicated for the topical treatment of external genital warts (Condyloma acuminatum). This product is not indicated in the treatment of perianal or mucous membrane warts (see PRECAUTIONS ). Diagnosis Although genital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma (so-called "Bowenoid papulosis") is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus but should not be treated with Podofilox Topical Solution 0.5%.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-0611

What is NDC 0574-0611?: 0574-0611 is the product NDC for Podofilox, Podofilox 5 mg/mL solution, listed with the FDA by Padagis US LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Podofilox.
What is the active ingredient?: Podofilox.
Who is the labeler?: Padagis US LLC, NDC labeler code 0574. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Podofilox?: 1 other product NDC are listed under this name. See all Podofilox 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 Podofilox NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Podofilox	Podofilox 5 mg/g	GelTopical	Padagis US LLC	0574-0621	00574-0621-05