What is NDC 51862-362?

51862-362 is the product NDC for Fluorouracil, Fluorouracil 50 mg/g cream, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Fluorouracil?

40 other product NDCs are listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Fluorouracil NDC 51862-362 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)51862-362Labeler and product segments. Claims need a package NDC.

Product NDC at billing width51862-0362Add 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
51862-362-40	5186203624051862036240	1 TUBE in 1 CARTON (51862-362-40) / 40 g in 1 TUBEMarketed from Dec 3, 2019

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): Fluorouracil
Generic name (nonproprietary): fluorouracil
Active ingredients: Fluorouracil — 50 mg/g
Dosage form: Cream
Route: Topical
Labeler: Mayne Pharma Inc.NDC labeler code 51862
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077524
Marketing start: Dec 3, 2019
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 51862-362_d05a8a27-b7f9-40cc-a36a-97209fc998b1SPL ID d05a8a27-b7f9-40cc-a36a-97209fc998b1SPL set ID 06475bd8-66d9-4f88-90e4-b367480dab39RxCUI 105583UNII 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

N451862036240 followed by a unit qualifier and the quantity

Package 51862-0362-40. 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 Nov 4, 2021.

Indications (excerpt from the label)

INDICATIONS AND USAGE Fluorouracil Cream is recommended for the topical treatment of multiple actinic or solar keratoses. In the 5% strength, it is also useful in the treatment of superficial basal cell carcinomas when conventional methods are impractical, such as with multiple lesions or difficult treatment sites. Safety and efficacy in other indications have not been established. The diagnosis should be established prior to treatment, since this method has not been proven effective in other types of basal cell carcinomas. With isolated, easily accessible basal cell carcinomas, surgery is preferred since success with such lesions is almost 100%. The success rate with Fluorouracil Cream is a…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 51862-362

What is NDC 51862-362?: 51862-362 is the product NDC for Fluorouracil, Fluorouracil 50 mg/g cream, listed with the FDA by Mayne Pharma Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Fluorouracil.
What is the active ingredient?: Fluorouracil.
Who is the labeler?: Mayne Pharma Inc., NDC labeler code 51862. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Fluorouracil?: 40 other product NDCs are listed under this name. See all Fluorouracil 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 Fluorouracil NDCs
Product	Strength	Form · route	Labeler	Product NDC	Package NDCs (11-digit)
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-972	23155-0972-41
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-973	23155-0973-41
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-974	23155-0974-31
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	23155-975	23155-0975-31
Fluorouracilfluorouracil cream, 0.5%	Fluorouracil 5 mg/g	CreamTopical	Dr. Reddy's Laboratories Inc.	75907-169	75907-0169-11
Fluorouracil	Fluorouracil 2 g/40g	CreamTopical	Encube Ethicals, Inc.	21922-049	21922-0049-17
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-154	71288-0154-76
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-628	68001-0628-32
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	BluePoint Laboratories	68001-627	68001-0627-27
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Meitheal Pharmaceuticals Inc.	71288-170	71288-0170-75

All 41 Fluorouracil NDCs

Other NDCs under ANDA 077524

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

FDA NDC Directory listings under ANDA 077524
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 50 mg/g	CreamTopical	Dr. Reddy's Labratories Inc.	75907-095