What is NDC 50419-325?

50419-325 is the product NDC for Gadavist (gadobutrol), Gadobutrol 604.72 mg/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 12 package NDCs, shown above in 10- and 11-digit form.

Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gadavist?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

Gadavist NDC 50419-325 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)50419-325Labeler and product segments. Claims need a package NDC.

Product NDC at billing width50419-0325Add 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
50419-325-11	50419032511	2 CARTON in 1 BOX (50419-325-11) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 7.5 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-12	50419032512	2 CARTON in 1 BOX (50419-325-12) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-13	50419032513	2 CARTON in 1 BOX (50419-325-13) / 10 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-27	50419032527	5 SYRINGE, GLASS in 1 BOX (50419-325-27) / 7.5 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-28	50419032528	5 SYRINGE, GLASS in 1 BOX (50419-325-28) / 10 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-29	50419032529	5 SYRINGE, GLASS in 1 BOX (50419-325-29) / 15 mL in 1 SYRINGE, GLASSMarketed from Mar 15, 2011
50419-325-37	50419032537	15 CARTON in 1 BOX (50419-325-37) / 3 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011
50419-325-67	50419032567	5 SYRINGE, PLASTIC in 1 BOX (50419-325-67) / 7.5 mL in 1 SYRINGE, PLASTICMarketed from Jul 28, 2026
50419-325-68	50419032568	5 SYRINGE, PLASTIC in 1 BOX (50419-325-68) / 10 mL in 1 SYRINGE, PLASTICMarketed from Jul 28, 2026
50419-325-69	50419032569	5 SYRINGE, PLASTIC in 1 BOX (50419-325-69) / 15 mL in 1 SYRINGE, PLASTICMarketed from Jul 28, 2026
50419-325-72	50419032572	10 VIAL, SINGLE-DOSE in 1 CARTON (50419-325-72) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Mar 15, 2011 · Sample package
50419-325-75	50419032575	5 SYRINGE, GLASS in 1 BOX (50419-325-75) / 10 mL in 1 SYRINGE, GLASSMarketed from May 12, 2022 · Sample package

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): Gadavist
Generic name (nonproprietary): gadobutrol
Active ingredients: Gadobutrol — 604.72 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type: Prescription drug
Marketing category: NDA — New Drug ApplicationApplication NDA 201277
Marketing start: Mar 14, 2011
Listing expires: Dec 31, 2027
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 50419-325_ca35e789-adaa-45b2-8ec1-b52f2ff13ce2SPL ID ca35e789-adaa-45b2-8ec1-b52f2ff13ce2
Pharmacologic class: Gadolinium-based Contrast Agent

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

N450419032511 followed by a unit qualifier and the quantity

Package 50419-0325-11. 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

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

About NDC 50419-325

What is NDC 50419-325?: 50419-325 is the product NDC for Gadavist (gadobutrol), Gadobutrol 604.72 mg/mL injection, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 12 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gadavist (Gadobutrol).
What is the active ingredient?: Gadobutrol.
Who is the labeler?: Bayer HealthCare Pharmaceuticals Inc., NDC labeler code 50419. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gadavist?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Gadavist (Gadobutrol) NDC 50419-325