Fluorouracil NDC 68001-628

NDC codes

FDA NDC Directory

Product NDC (as listed)68001-628Labeler and product segments. Claims need a package NDC.

Product NDC at billing width68001-0628Add 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
68001-628-32	68001062832	1 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-628-32) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Jan 31, 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
Active ingredients: Fluorouracil — 50 mg/mL
Dosage form: Injection, Solution
Route: Intravenous
Labeler: BluePoint Laboratories
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 217676
Marketing start: Jan 31, 2025
Listing expires: Dec 31, 2027
Other FDA classes: Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers: Product ID 68001-628_568fddd9-9cce-0fc3-e063-6294a90a1f5cSPL ID 568fddd9-9cce-0fc3-e063-6294a90a1f5cSPL set ID c612b05f-f37d-47fa-9c1e-b2d876dd7093RxCUI 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.

How CPT relates to drug billing

NDC on a medical claim

N468001062832 followed by a unit qualifier and the quantity

Package 68001-0628-32. 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 Jul 14, 2026. This label includes a boxed warning.

Indications (excerpt from the label)

Fluorouracil is indicated for the treatment of patients with: 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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 217676

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

FDA NDC Directory listings under ANDA 217676
Product	Strength	Form · route	Labeler	Product NDC
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Alembic Pharmaceuticals Inc.	62332-779
Fluorouracil	Fluorouracil 50 mg/mL	Injection, SolutionIntravenous	Alembic Pharmaceuticals Limited	46708-779