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  5. NDC Package Code: 70436-214-80 Gadobutrol

NDC Package 70436-214-80 Gadobutrol

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

Table of Contents

    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. 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:
70436-214-80
Package Description:
1 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)
Product Code:
70436-214
Proprietary Name:
Gadobutrol
Non-Proprietary Name:
Gadobutrol
Substance Name:
Gadobutrol
Usage Information:
Gadobutrol injection is contraindicated in patients with history of severe hypersensitivity reactions to gadobutrol injection.
11-Digit NDC Billing Format:
70436021480
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):
GADOBUTROL 604.72 mg/mL
Pharmacologic Class(es):
Sample Package:
No
FDA Application Number:
ANDA217480
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
10-20-2023
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 70436-214-80 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
70436021480A9585Gadobutrol injection0.1 ML151150150

* Please review the disclaimer below.

Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
70436-214-5420 VIAL, SINGLE-DOSE in 1 CARTON / 15 mL in 1 VIAL, SINGLE-DOSE (70436-214-34)

* Please review the disclaimer below.

Frequently Asked Questions

What is NDC 70436-214-80?

The NDC Packaged Code 70436-214-80 is assigned to a package of 1 vial, single-dose in 1 carton / 15 ml in 1 vial, single-dose (70436-214-34) of Gadobutrol, 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 70436-214 included in the NDC Directory?

Yes, Gadobutrol with product code 70436-214 is active and included in the NDC Directory. The product was first marketed by Slate Run Pharmaceuticals, Llc on October 20, 2023 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 70436-214-80?

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 70436-214-80?

The 11-digit format is 70436021480. 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
5-3-270436-214-805-4-270436-0214-80