NDC codes

FDA NDC Directory
Product NDC (as listed)72078-048Labeler and product segments. Claims need a package NDC.
Product NDC at billing width72078-0048Add 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
72078-048-2072078004820720780048201 VIAL, SINGLE-DOSE in 1 CARTON (72078-048-20) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 31, 2026

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)
Ferric Carboxymaltose
Generic name (nonproprietary)
ferric carboxymaltose
Active ingredients
Ferric carboxymaltose — 50 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Mylan Institutional LLCNDC labeler code 72078
Product type
Prescription drug
Marketing category
ANDA — Abbreviated New Drug Application (generic)Application ANDA 217076
Marketing start
Listing expires
Other FDA classes
Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers
Product ID 72078-048_28262895-c0df-473b-86dd-02b2368af632SPL ID 28262895-c0df-473b-86dd-02b2368af632
Pharmacologic class
Parenteral Iron Replacement; Phosphate Binder

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

N472078004820 followed by a unit qualifier and the quantity

Package 72078-0048-20. 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.

About NDC 72078-048

What is NDC 72078-048?
72078-048 is the product NDC for Ferric Carboxymaltose, Ferric carboxymaltose 50 mg/mL injection, solution, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Ferric Carboxymaltose.
What is the active ingredient?
Ferric carboxymaltose.
Who is the labeler?
Mylan Institutional LLC, NDC labeler code 72078. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Ferric Carboxymaltose?
3 other product NDCs are listed under this name. See all Ferric Carboxymaltose 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 Ferric Carboxymaltose NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Ferric Carboxymaltoseferric carboxymaltose injectionFerric carboxymaltose 50 mg/mLInjection, SolutionIntravenousSandoz, Inc.0781-354200781-3542-94
Ferric CarboxymaltoseFerric carboxymaltose 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC67457-79767457-0797-15
Ferric CarboxymaltoseFerric carboxymaltose 50 mg/mLInjection, SolutionIntravenousMylan Institutional LLC72078-06072078-0060-99

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