NDC codes

FDA NDC Directory
Product NDC (as listed)50419-320Labeler and product segments. Claims need a package NDC.
Product NDC at billing width50419-0320Add 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
50419-320-05504190320055 VIAL, SINGLE-DOSE in 1 BOX (50419-320-05) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 3, 2008
50419-320-15504190320155 VIAL, SINGLE-DOSE in 1 BOX (50419-320-15) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 3, 2008
50419-320-75504190320755 VIAL, SINGLE-DOSE in 1 BOX (50419-320-75) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Jul 3, 2008

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)
Eovist
Generic name (nonproprietary)
gadoxetate disodium
Active ingredients
Gadoxetate disodium — 181.43 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Bayer HealthCare Pharmaceuticals Inc.NDC labeler code 50419
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 022090
Marketing start
Listing expires
Other FDA classes
Magnetic Resonance Contrast Activity (Mechanism)
Identifiers
Product ID 50419-320_21b68b8a-33ca-4b8a-9981-bb52c48674c2SPL ID 21b68b8a-33ca-4b8a-9981-bb52c48674c2SPL set ID 6218b1e1-cbc3-4c14-bec7-528ac163a561UNII HOY74VZE0M
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

N450419032005 followed by a unit qualifier and the quantity

Package 50419-0320-05. 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 . This label includes a boxed warning.

Indications (excerpt from the label)

EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. EOVIST is a gadolinium-based contrast agent indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. ( 1 )

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 50419-320

What is NDC 50419-320?
50419-320 is the product NDC for Eovist (gadoxetate disodium), Gadoxetate disodium 181.43 mg/mL injection, solution, listed with the FDA by Bayer HealthCare Pharmaceuticals Inc.. It has 3 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
Eovist (Gadoxetate Disodium).
What is the active ingredient?
Gadoxetate disodium.
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 Eovist?
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.

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