Granisetron Hydrochloride Tablet, Film Coated
NDC Package 69452-350-92

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. NDC HCPCS Crosswalk
    3. Other Packages
    4. Frequently Asked Questions

Package 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. This formulation utilizes a tablet, film coated delivery system. Marketed by Bionpharma Inc., this product is identified by NDC 69452-350 and is authorized under FDA application ANDA078678.

Identification & Billing

NDC Package Code
69452-350-92
Package Description
2 BLISTER PACK in 1 CARTON / 10 TABLET, FILM COATED in 1 BLISTER PACK
Product Code
69452-350
11-Digit Billing Format
69452035092
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
2 EA
RxNorm Crosswalk

Clinical Specifications

Proprietary Name
Granisetron Hydrochloride
Non-Proprietary Name
Granisetron Hydrochloride
Substance Name
Granisetron Hydrochloride
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
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GRANISETRON HYDROCHLORIDE 1 mg/1
Pharmacologic Class
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.

Regulatory & Marketing

Labeler Name
Bionpharma Inc.
Product Type
Human Prescription Drug
FDA Application #
ANDA078678
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
02-28-2022
Listing Expiration
12-31-2026
Exclude Flag
N
Sample Package
No

Hierarchy Structure

Code Lineage

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 full disclaimer at the bottom of this page.

Billing & HCPCS Mapping

To facilitate insurance claims and reimbursement, this drug package is mapped to specific HCPCS administrative codes. This crosswalk aligns clinical data with the billing standards used in ASP (Average Sales Price), AWP, and OPPS payment systems. Use the cards below to identify the correct billable units for provider claims.

Q0166
Source: PDAC
GRANISETRON 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 REGIMEN
HCPCS Dosage 1 MG
Units / Pkg

Note for Medical Coders: These mappings are synthesized from various CMS datasets including OPPS, PrEP, and DAC (Data Analysis and Coding) contractors. Always confirm unit conversions against the current quarter's pricing files before final submission.

* Please review the full disclaimer at the bottom of this page.

Other Available Packages

The following commercial packages are registered under the same Product NDC (69452-350). Click a package code to view its specific billing and regulatory data.

69452-350-01
2 BLISTER PACK in 1 CARTON / 1 TABLET, FILM COATED in 1 BLISTER PACK
69452-350-11
20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

* Please review the full disclaimer at the bottom of this page.

Frequently Asked Questions

What is the distribution configuration for this product package?

The code 69452-350-92 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack of Granisetron Hydrochloride, a human prescription drug labeled by Bionpharma Inc.. This tablet, film coated is formulated for oral use and contains granisetron hydrochloride as the active substance.

Is this product currently listed with the FDA?

Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Bionpharma Inc. on February 28, 2022. The current certification is valid through December 31, 2026.

How is this Bionpharma Inc. product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 69452035092. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.

11-Digit Code Conversion

Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:

10-Digit Format (5-3-2)
69452-350-92
11-Digit CMS (5-4-2)
69452-0350-92

Note: The zero is added to the Product segment to maintain the 5-4-2 structure.