What is NDC 75907-095?

75907-095 is the product NDC for Fluorouracil, Fluorouracil 50 mg/g cream, listed with the FDA by Dr. Reddy's Labratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.

Dr. Reddy's Labratories Inc., NDC labeler code 75907. 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 75907-095 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)75907-095Labeler and product segments. Claims need a package NDC.

Product NDC at billing width75907-0095Add 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
75907-095-40	7590700954075907009540	1 TUBE in 1 CARTON (75907-095-40) / 40 g in 1 TUBEMarketed from Apr 15, 2024

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: Dr. Reddy's Labratories Inc.NDC labeler code 75907
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 077524
Marketing start: Apr 15, 2024
Listing expires: Dec 31, 2026
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 75907-095_984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3SPL ID 984dd0bc-f7a7-b4a9-6d64-0b45a161d9d3SPL set ID e137c766-1f7f-0251-90b9-450c3d4d78b9RxCUI 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

N475907009540 followed by a unit qualifier and the quantity

Package 75907-0095-40. 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 Apr 1, 2024.

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 75907-095

What is NDC 75907-095?: 75907-095 is the product NDC for Fluorouracil, Fluorouracil 50 mg/g cream, listed with the FDA by Dr. Reddy's Labratories 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?: Dr. Reddy's Labratories Inc., NDC labeler code 75907. 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	Mayne Pharma Inc.	51862-362