NDC Package 69452-350-11 Granisetron Hydrochloride

Tablet, Film Coated Oral - 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:
69452-350-11
Package Description:
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
Product Code:
Proprietary Name:
Granisetron Hydrochloride
Non-Proprietary Name:
Granisetron Hydrochloride
Substance Name:
Granisetron Hydrochloride
Usage Information:
Granisetron hydrochloride tablets are indicated for the prevention of:Nausea and vomiting associated with initial and repeat courses of emetogenic cancer therapy, including high-dose cisplatin.Nausea and vomiting associated with radiation, including total body irradiation and fractionated abdominal radiation.
11-Digit NDC Billing Format:
69452035011
Billing Unit:
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
NDC to RxNorm Crosswalk:
20 EA
NDC to RxNorm Crosswalk:
Product Type:
Human Prescription Drug
Labeler Name:
Bionpharma Inc.
Dosage Form:
Tablet, Film Coated - A solid dosage form that contains medicinal substances with or without suitable diluents and is coated with a thin layer of a water-insoluble or water-soluble polymer.
Administration Route(s):
Oral - Administration to or by way of the mouth.
Sample Package:
No
FDA Application Number:
ANDA078678
Marketing Category:
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date:
02-28-2022
Listing Expiration Date:
12-31-2025
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.

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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 69452-350-11 HCPCS crosswalk information with package details and bill units information.

NDC Billing CodeHCPCS CodeHCPCS Code Desc.DosagePackage SizePackage QuantityBillable UnitsBillable Units / Pkg
69452035011Q0166GRANISETRON HYDROCHLORIDE, 1 MG, ORAL, FDA APPROVED PRESCRIPTION ANTI-EMETIC, FOR USE AS A COMPLETE THERAPEUTIC SUBSTITUTE FOR AN IV ANTI-EMETIC AT THE TIME OF CHEMOTHERAPY TREATMENT, NOT TO EXCEED A 24 HOUR DOSAGE REGIMEN1 MG20EA

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Other Product Packages

The following packages are also available for this product:

NDC Package CodePackage Description
69452-350-012 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
69452-350-922 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK

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Frequently Asked Questions

What is NDC 69452-350-11?

The NDC Packaged Code 69452-350-11 is assigned to a package of 20 tablet, film coated in 1 bottle, plastic of Granisetron Hydrochloride, a human prescription drug labeled by Bionpharma Inc.. The product's dosage form is tablet, film coated and is administered via oral form.

Is NDC 69452-350 included in the NDC Directory?

Yes, Granisetron Hydrochloride with product code 69452-350 is active and included in the NDC Directory. The product was first marketed by Bionpharma Inc. on February 28, 2022 and its listing in the NDC Directory is set to expire on December 31, 2025 if the product is not updated or renewed by the manufacturer.

What is the NDC billing unit for package 69452-350-11?

The contents of this package are billed per "each", products billed on a per each basis are usually products dispensed in discreet units. The calculated billable units for this package is 20.

What is the 11-digit format for NDC 69452-350-11?

The 11-digit format is 69452035011. 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
5-3-269452-350-115-4-269452-0350-11