What is NDC 47335-994?

47335-994 is the product NDC for Winlevi (clascoterone), Clascoterone 1 g/100g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.

Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Winlevi?

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.

Winlevi NDC 47335-994 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)47335-994Labeler and product segments. Claims need a package NDC.

Product NDC at billing width47335-0994Add 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
47335-994-36	47335099436	1 TUBE in 1 CARTON (47335-994-36) / 60 g in 1 TUBEMarketed from Oct 4, 2021
47335-994-94	47335099494	12 CARTON in 1 CASE (47335-994-94) / 1 TUBE in 1 CARTON (47335-994-40) / 2 g in 1 TUBEMarketed from Oct 4, 2021 · Sample package

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): Winlevi
Generic name (nonproprietary): clascoterone
Active ingredients: Clascoterone — 1 g/100g
Dosage form: Cream
Route: Topical
Labeler: Sun Pharmaceutical Industries, Inc.NDC labeler code 47335
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 213433
Marketing start: Oct 4, 2021
Listing expires: Dec 31, 2026
Other FDA classes: Androgen Receptor Antagonists (Mechanism)
Identifiers: Product ID 47335-994_2abfc28a-6f85-d793-e063-6394a90a9490SPL ID 2abfc28a-6f85-d793-e063-6394a90a9490SPL set ID 1673a84b-7f5c-47ab-a99c-1e3db21a6a09RxCUI 2474344, 2474349UNII XN7MM8XG2MUPC 0347335994360
Pharmacologic class: Androgen Receptor Inhibitor

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

N447335099436 followed by a unit qualifier and the quantity

Package 47335-0994-36. 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 Jan 2, 2025.

Indications (excerpt from the label)

WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI (clascoterone) cream is an androgen receptor inhibitor indicated for the topical treatment of acne vulgaris in patients 12 years of age and older. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 47335-994

What is NDC 47335-994?: 47335-994 is the product NDC for Winlevi (clascoterone), Clascoterone 1 g/100g cream, listed with the FDA by Sun Pharmaceutical Industries, Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Winlevi (Clascoterone).
What is the active ingredient?: Clascoterone.
Who is the labeler?: Sun Pharmaceutical Industries, Inc., NDC labeler code 47335. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Winlevi?: 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.

Winlevi (Clascoterone) NDC 47335-994