Prescription drug · NDA AUTHORIZED GENERIC
Fluorouracil (Fluorouracil cream, 0.5%) NDC 75907-169
Fluorouracil 5 mg/g · Cream · Topical · Dr. Reddy's Laboratories Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 75907-169-11 | 7590701691175907016911 | 1 TUBE in 1 CARTON (75907-169-11) / 30 g in 1 TUBEMarketed from Jul 6, 2025 |
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 cream, 0.5%
- Active ingredients
- Fluorouracil — 5 mg/g
- Dosage form
- Cream
- Route
- Topical
- Labeler
- Dr. Reddy's Laboratories Inc.NDC labeler code 75907
- Product type
- Prescription drug
- Marketing category
- NDA authorized genericApplication NDA 020985
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 75907-169_39a2cbc0-f588-5397-e063-6394a90a5390SPL ID 39a2cbc0-f588-5397-e063-6394a90a5390SPL set ID 37dcfb83-0e7d-d23d-9cd5-afa5bdc30628RxCUI 284191UNII 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
N475907016911followed by a unit qualifier and the quantityPackage 75907-0169-11. 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 .
Indications (excerpt from the label)
INDICATIONS AND USAGE Fluorouracil cream, 0.5% is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
Excerpt only. Read the full label for complete information.
About NDC 75907-169
- What is NDC 75907-169?
- 75907-169 is the product NDC for Fluorouracil, Fluorouracil 5 mg/g cream, listed with the FDA by Dr. Reddy's Laboratories Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Fluorouracil (Fluorouracil Cream, 0.5%).
- What is the active ingredient?
- Fluorouracil.
- Who is the labeler?
- Dr. Reddy's Laboratories 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.
Related NDCs: other Fluorouracil products
Other finished products listed under the same name: strengths, forms and labelers.
| 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 |
| 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 |
| Fluorouracil | Fluorouracil 50 mg/g | CreamTopical | Dr. Reddy's Labratories Inc. | 75907-095 | 75907-0095-40 |