Prescription drug · ANDA
Fluorouracil NDC 46708-751
Fluorouracil 50 mg/mL · Injection, Solution · Intravenous · Alembic Pharmaceuticals Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46708-751-50 | 4670807515046708075150 | 1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (46708-751-50) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Mar 3, 2023 |
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/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Alembic Pharmaceuticals LimitedNDC labeler code 46708
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217295
- Marketing start
- Listing expires
- Other FDA classes
- Nucleic Acid Synthesis Inhibitors (Mechanism)
- Identifiers
- Product ID 46708-751_d10f12a2-7b38-4351-93df-1e8444d2a9e4SPL ID d10f12a2-7b38-4351-93df-1e8444d2a9e4SPL set ID d10f12a2-7b38-4351-93df-1e8444d2a9e4RxCUI 239177UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N446708075150followed by a unit qualifier and the quantityPackage 46708-0751-50. 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)
Fluorouracil is a nucleoside metabolic inhibitor indicated for the treatment of patients with • Adenocarcinoma of the Colon and Rectum ( 1.1 ) • Adenocarcinoma of the Breast ( 1.2 ) • Gastric Adenocarcinoma ( 1.3 ) • Pancreatic Adenocarcinoma ( 1.4 ) 1.1 Adenocarcinoma of the Colon and Rectum . 1.2 Adenocarcinoma of the Breast . 1.3 Gastric Adenocarcinoma . 1.4 Pancreatic Adenocarcinoma .
Excerpt only. Read the full label for complete information.
About NDC 46708-751
- What is NDC 46708-751?
- 46708-751 is the product NDC for Fluorouracil, Fluorouracil 50 mg/mL injection, solution, listed with the FDA by Alembic Pharmaceuticals Limited. 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?
- Alembic Pharmaceuticals Limited, NDC labeler code 46708. 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 |
| 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 |
Other NDCs under ANDA 217295
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | Alembic Pharmaceuticals Inc. | 62332-751 |
| Fluorouracil | Fluorouracil 50 mg/mL | Injection, SolutionIntravenous | BluePoint Laboratories | 68001-627 |