What is NDC 0574-0621?

0574-0621 is the product NDC for Podofilox, Podofilox 5 mg/g gel, 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 0574-0621 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0574-0621Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00574-0621Add 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
0574-0621-05	0057406210500574062105	3.5 g in 1 TUBE, WITH APPLICATOR (0574-0621-05)Marketed from Dec 13, 2023

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/g
Dosage form: Gel
Route: Topical
Labeler: Padagis US LLCNDC labeler code 0574
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 211871
Marketing start: Dec 13, 2023
Listing expires: Dec 31, 2026
Other FDA classes: Decreased Mitosis (Physiologic effect)
Identifiers: Product ID 0574-0621_d2e70c5e-d4a9-4295-9eff-517ffb974e61SPL ID d2e70c5e-d4a9-4295-9eff-517ffb974e61SPL set ID d2e70c5e-d4a9-4295-9eff-517ffb974e61RxCUI 312466UNII 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

N400574062105 followed by a unit qualifier and the quantity

Package 00574-0621-05. 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 May 1, 2023.

Indications (excerpt from the label)

INDICATIONS AND USAGE Podofilox gel is indicated for the topical treatment of anogenital warts (external genital warts and perianal warts). This product is not indicated in the treatment of mucous membrane warts (see PRECAUTIONS ). Diagnosis Although anogenital warts have a characteristic appearance, histopathologic confirmation should be obtained if there is any doubt of the diagnosis. Differentiating warts from squamous cell carcinoma and "Bowenoid papulosis" is of particular concern. Squamous cell carcinoma may also be associated with human papillomavirus which should not be treated with podofilox gel.

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0574-0621

What is NDC 0574-0621?: 0574-0621 is the product NDC for Podofilox, Podofilox 5 mg/g gel, 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/mL	SolutionTopical	Padagis US LLC	0574-0611	00574-0611-05