What is NDC 28105-421?

28105-421 is the product NDC for Tolak (fluorouracil), Fluorouracil .04 g/g cream, listed with the FDA by HILL DERMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.

HILL DERMACEUTICALS, INC., NDC labeler code 28105. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Tolak?

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.

Tolak NDC 28105-421 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)28105-421Labeler and product segments. Claims need a package NDC.

Product NDC at billing width28105-0421Add 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
28105-421-40	28105042140	1 TUBE in 1 CARTON (28105-421-40) / 40 g in 1 TUBEMarketed from Sep 18, 2015

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): Tolak
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — .04 g/g
Dosage form: Cream
Route: Topical
Labeler: HILL DERMACEUTICALS, INC.NDC labeler code 28105
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 022259
Marketing start: Sep 18, 2015
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 28105-421_db3a1489-fcb1-4442-b309-4eb8ad9b9f46SPL ID db3a1489-fcb1-4442-b309-4eb8ad9b9f46SPL set ID 59de2709-00b8-4f0a-867c-f0dfeb947192RxCUI 1669868, 1669873UNII 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.

NDC on a medical claim

N428105042140 followed by a unit qualifier and the quantity

Package 28105-0421-40. 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 Sep 6, 2022.

Indications (excerpt from the label)

Tolak (fluorouracil) Cream is indicated for the topical treatment of actinic keratosis lesions of the face, ears, and/or scalp. Tolak (fluorouracil) Cream, 4%, is a nucleoside metabolic inhibitor indicated for the topical treatment of actinic keratosis lesions of the face, ears, and scalp ( 1 ).

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 28105-421

What is NDC 28105-421?: 28105-421 is the product NDC for Tolak (fluorouracil), Fluorouracil .04 g/g cream, listed with the FDA by HILL DERMACEUTICALS, INC.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Tolak (Fluorouracil).
What is the active ingredient?: Fluorouracil.
Who is the labeler?: HILL DERMACEUTICALS, INC., NDC labeler code 28105. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Tolak?: 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.

Tolak (Fluorouracil) NDC 28105-421