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  5. NDC Package Code: 70436-121-35 Gadoteridol

NDC Package 70436-121-35 Gadoteridol

Injection Intravenous - View Billable Units, 11-Digit Format, RxNorm

Table of Contents

    1. Package Information
    2. Other Packages
    3. Frequently Asked Questions

Package Information

Find all the important details about this NDC Package code, including the 11-Digit NDC Billing number, billing units, wholesale price, RxNorm crosswalk, active ingredients, pharmacologic clasess, etc.

NDC Package Code:
70436-121-35
Package Description:
5 VIAL, SINGLE-DOSE in 1 CARTON / 20 mL in 1 VIAL, SINGLE-DOSE
Product Code:
70436-121
Proprietary Name:
Gadoteridol
Non-Proprietary Name:
Gadoteridol
Substance Name:
Gadoteridol
Usage Information:
Gadoteridol Injection is contraindicated in patients with known allergic or hypersensitivity reactions to Gadoteridol Injection [see Warnings and Precautions ( 5.3)] .
11-Digit NDC Billing Format:
70436012135
Billing Unit:
ML - Billing unit of "milliliter" is used when a product is measured by its liquid volume.
Product Type:
Human Prescription Drug
Labeler Name:
Slate Run Pharmaceuticals, Llc
Dosage Form:
Injection - A sterile preparation intended for parenteral use; five distinct classes of injections exist as defined by the USP.
Administration Route(s):
Intravenous - Administration within or into a vein or veins.
Active Ingredient(s):
GADOTERIDOL 279.3 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA218749
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-20-2025
Listing Expiration Date:
12-31-2026
Exclude Flag:
N
Code Structure:

The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
70436-121-315 VIAL, SINGLE-DOSE in 1 CARTON / 5 mL in 1 VIAL, SINGLE-DOSE
70436-121-335 VIAL, SINGLE-DOSE in 1 CARTON / 10 mL in 1 VIAL, SINGLE-DOSE
70436-121-345 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70436-121-35?

The NDC Packaged Code 70436-121-35 is assigned to a package of 5 vial, single-dose in 1 carton / 20 ml in 1 vial, single-dose of Gadoteridol, a human prescription drug labeled by Slate Run Pharmaceuticals, Llc. The product's dosage form is injection and is administered via intravenous form.

Is NDC 70436-121 included in the NDC Directory?

Yes, Gadoteridol with product code 70436-121 is active and included in the NDC Directory. The product was first marketed by Slate Run Pharmaceuticals, Llc on February 20, 2025 and its listing in the NDC Directory is set to expire on December 31, 2026 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 70436-121-35?

The contents of this package are billed per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.

What is the 11-digit format for NDC 70436-121-35?

The 11-digit format is 70436012135. The 11-digit billing format might be required by the Centers for Medicare & Medicaid Services (CMS) and other payers in billing claim forms.

This package code is originally configured in a 5-3-2 segment 10-digit format and by adding a zero within the original NDC package code we can obtain the converted 11-digit format in a 5-4-2 segment configuration. The table below shows the 11-digit code conversion:

10-Digit Format10-Digit Original Code11-Digit Format11-Digit Code
5-3-270436-121-355-4-270436-0121-35