NDC codes

FDA NDC Directory
Product NDC (as listed)0270-1111Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00270-1111Add 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
0270-1111-7000270111170002701111705 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Oct 9, 2003
0270-1111-8500270111185002701111855 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-85) / 100 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Feb 1, 2022

How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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)
ProHance
Generic name (nonproprietary)
gadoteridol
Active ingredients
Gadoteridol — 279.3 mg/mL
Dosage form
Injection, Solution
Route
Intravenous
Labeler
Bracco Diagnostics IncNDC labeler code 0270
Product type
Prescription drug
Marketing category
NDA — New Drug ApplicationApplication NDA 021489
Marketing start
Listing expires
Other FDA classes
Magnetic Resonance Contrast Activity (Mechanism)
Identifiers
Product ID 0270-1111_ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2SPL ID ecd7e9ad-58e6-b31c-0b80-cce5b07fcad2SPL set ID e8b76200-c0aa-491b-aad7-e22d2f68496fUNII 0199MV609F
Pharmacologic class
Paramagnetic 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

N400270111170 followed by a unit qualifier and the quantity

Package 00270-1111-70. 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)

ProHance Multipack is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues in adults and pediatric patients, including term neonates ( 1.1 ) lesions in the head and neck in adults ( 1.2 ) 1.1 MRI of the Central Nervous System (CNS) ProHance is indicated for magnetic resonance imaging (MRI) in adults and pediatric patients including term neonates to visualize lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tissues. 1.2 MRI of Extracrania…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 0270-1111

What is NDC 0270-1111?
0270-1111 is the product NDC for ProHance (gadoteridol), Gadoteridol 279.3 mg/mL injection, solution, listed with the FDA by Bracco Diagnostics Inc. It has 2 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?
ProHance (Gadoteridol).
What is the active ingredient?
Gadoteridol.
Who is the labeler?
Bracco Diagnostics Inc, NDC labeler code 0270. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for ProHance?
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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