NDC codes

FDA NDC Directory
Product NDC (as listed)68001-525Labeler and product segments. Claims need a package NDC.
Product NDC at billing width68001-0525Add 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 NDC11-digit (billing)PackageCopy
68001-525-27680010525271 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-27) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Feb 18, 2022
68001-525-32680010525321 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (68001-525-32) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Feb 18, 2022

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
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 210124
Marketing start
Listing expires
Other FDA classes
Nucleic Acid Synthesis Inhibitors (Mechanism)
Identifiers
Product ID 68001-525_5c040168-a04b-cbb1-e063-6394a90a93f4SPL ID 5c040168-a04b-cbb1-e063-6394a90a93f4
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

N468001052527 followed by a unit qualifier and the quantity

Package 68001-0525-27. 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

The FDA listing for this product does not reference a label (SPL) set.

Other NDCs under ANDA 210124

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

FDA NDC Directory listings under ANDA 210124
ProductStrengthForm · routeLabelerProduct NDC
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousGland Pharma Limited68083-292
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousGland Pharma Limited68083-293
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousXiromed LLC70700-189
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousXiromed LLC70700-188
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-974
FluorouracilFluorouracil 50 mg/mLInjection, SolutionIntravenousHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.23155-975

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