Prescription drug · NDA
ProHance (Gadoteridol) NDC 0270-1111
Gadoteridol 279.3 mg/mL · Injection, Solution · Intravenous · Bracco Diagnostics Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0270-1111-70 | 0027011117000270111170 | 5 VIAL, PHARMACY BULK PACKAGE in 1 BOX (0270-1111-70) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGEMarketed from Oct 9, 2003 | |
| 0270-1111-85 | 0027011118500270111185 | 5 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.
- NDC on a medical claim
N400270111170followed by a unit qualifier and the quantityPackage 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.
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.