What is NDC 70436-121?

70436-121 is the product NDC for Gadoteridol, Gadoteridol 279.3 mg/mL injection, listed with the FDA by Slate Run Pharmaceuticals, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.

Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for Gadoteridol?

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.

Gadoteridol NDC 70436-121 | National Drug Code

NDC codes

FDA NDC Directory

Product NDC (as listed)70436-121Labeler and product segments. Claims need a package NDC.

Product NDC at billing width70436-0121Add 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
70436-121-31	70436012131	5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-31) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 20, 2025
70436-121-33	70436012133	5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-33) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 20, 2025
70436-121-34	70436012134	5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-34) / 15 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 20, 2025
70436-121-35	70436012135	5 VIAL, SINGLE-DOSE in 1 CARTON (70436-121-35) / 20 mL in 1 VIAL, SINGLE-DOSEMarketed from Feb 20, 2025

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): Gadoteridol
Generic name (nonproprietary): gadoteridol
Active ingredients: Gadoteridol — 279.3 mg/mL
Dosage form: Injection
Route: Intravenous
Labeler: Slate Run Pharmaceuticals, LLCNDC labeler code 70436
Product type: Prescription drug
Marketing category: ANDA — Abbreviated New Drug Application (generic)Application ANDA 218749
Marketing start: Feb 20, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Magnetic Resonance Contrast Activity (Mechanism)
Identifiers: Product ID 70436-121_3f886711-cb41-3241-e063-6394a90a5bc7SPL ID 3f886711-cb41-3241-e063-6394a90a5bc7SPL set ID 538a70e0-061c-40d2-8447-5b7a4e61a55fUNII 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

N470436012131 followed by a unit qualifier and the quantity

Package 70436-0121-31. 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 Sep 24, 2025. This label includes a boxed warning.

Indications (excerpt from the label)

Gadoteridol Injection 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) Gadoteridol Injection 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…

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 70436-121

What is NDC 70436-121?: 70436-121 is the product NDC for Gadoteridol, Gadoteridol 279.3 mg/mL injection, listed with the FDA by Slate Run Pharmaceuticals, LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: Gadoteridol.
What is the active ingredient?: Gadoteridol.
Who is the labeler?: Slate Run Pharmaceuticals, LLC, NDC labeler code 70436. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for Gadoteridol?: 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.