NDC Package 70436-123-33 Gadoterate Meglumine

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

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:
70436-123-33
Package Description:
10 VIAL in 1 CARTON / 10 mL in 1 VIAL
Product Code:
Proprietary Name:
Gadoterate Meglumine
Non-Proprietary Name:
Gadoterate Meglumine
Substance Name:
Gadoterate Meglumine
Usage Information:
Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.
11-Digit NDC Billing Format:
70436012333
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.
  • Intravenous - Administration within or into a vein or veins.
Sample Package:
No
FDA Application Number:
ANDA218073
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
06-28-2024
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.

NDC HCPCS Crosswalk

This crosswalk is intended to help the public understand which drug products (identified by NDCs) are assigned to which HCPCS billing codes.

NDC 70436-123-33 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
70436012333A9575Inj gadoterate meglumi 0.1ml0.1 ML10101001000

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
70436-123-3110 VIAL in 1 CARTON / 5 mL in 1 VIAL
70436-123-3410 VIAL in 1 CARTON / 15 mL in 1 VIAL
70436-123-3510 VIAL in 1 CARTON / 20 mL in 1 VIAL
70436-123-566 VIAL in 1 CARTON / 100 mL in 1 VIAL (70436-123-40)
70436-123-801 VIAL in 1 CARTON / 100 mL in 1 VIAL (70436-123-40)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70436-123-33?

The NDC Packaged Code 70436-123-33 is assigned to a package of 10 vial in 1 carton / 10 ml in 1 vial of Gadoterate Meglumine, 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 70436-123 included in the NDC Directory?

Yes, Gadoterate Meglumine with product code 70436-123 is active and included in the NDC Directory. The product was first marketed by Slate Run Pharmaceuticals, Llc on June 28, 2024 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 70436-123-33?

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 70436-123-33?

The 11-digit format is 70436012333. 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
5-3-270436-123-335-4-270436-0123-33