What is NDC 0187-3204?

0187-3204 is the product NDC for Efudex (fluorouracil), Fluorouracil 2 g/40g cream, listed with the FDA by Bausch Health US, LLC.

Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Efudex?

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.

Efudex NDC 0187-3204 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)0187-3204Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00187-3204Add the package segment from the table below.

Product information

Brand name (proprietary): Efudex
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 2 g/40g
Dosage form: Cream
Route: Topical
Labeler: Bausch Health US, LLCNDC labeler code 0187
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 016831
Marketing start: Jul 29, 1970
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 0187-3204_3375c5f7-9b6f-8ca1-e063-6394a90aaff8SPL ID 3375c5f7-9b6f-8ca1-e063-6394a90aaff8SPL set ID 35de1c1c-bef5-46c5-b6f8-ea032147411cRxCUI 105583, 213045UNII U3P01618RT
Pharmacologic class: Nucleoside Metabolic 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.

Product label

Current FDA label (SPL), effective Apr 23, 2025.

Full label on DailyMed (opens in a new tab)

About NDC 0187-3204

What is NDC 0187-3204?: 0187-3204 is the product NDC for Efudex (fluorouracil), Fluorouracil 2 g/40g cream, listed with the FDA by Bausch Health US, LLC.
What drug is associated with this NDC?: Efudex (Fluorouracil).
What is the active ingredient?: Fluorouracil.
Who is the labeler?: Bausch Health US, LLC, NDC labeler code 0187. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Efudex?: 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.

Other NDCs under NDA 016831

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under NDA 016831
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 5 mg/g	CreamTopical	Mylan Pharmaceuticals Inc.	0378-4791

Efudex (Fluorouracil) NDC 0187-3204