Griseofulvin Microsize Tablet
NDC Package 23155-865-01

View Billable Units, 11-Digit Conversion Format, and RxNorm mappings
Table of Contents
    1. Package Information
    2. Frequently Asked Questions

Package Information

Griseofulvin Microsize (griseofulvin) tablets is griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.Griseofulvin may cause fetal harm when administered to a pregnant woman. This formulation utilizes a tablet delivery system. Marketed by Heritage Pharmaceuticals Inc D/b/a Avet Pharmaceuticals Inc, this product is identified by NDC 23155-865 and is authorized under FDA application ANDA060569.

Identification & Billing

NDC Package Code
23155-865-01
Package Description
100 TABLET in 1 BOTTLE, PLASTIC
Product Code
23155-865
11-Digit Billing Format
23155086501
Billing Unit
EA - Billing unit of "each" is used when the product is dispensed in discreet units.
Units Per Package
100 EA
RxNorm Crosswalk
RxCUI: 310600 - griseofulvin 500 MG Oral Tablet

Clinical Specifications

Proprietary Name
Griseofulvin Microsize
Non-Proprietary Name
Griseofulvin
Substance Name
Griseofulvin
Dosage Form
Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.
Administration Route
Oral - Administration to or by way of the mouth.
Active Ingredient(s)
GRISEOFULVIN 500 mg/1
Pharmacologic Class
Usage Information
Griseofulvin is contraindicated in patients with porphyria or hepatocellular failure, and in individuals with a history of hypersensitivity to griseofulvin.Griseofulvin may cause fetal harm when administered to a pregnant woman. Two published cases of conjoined twins have been reported in patients taking griseofulvin during the first trimester of pregnancy, therefore, griseofulvin is contraindicated in women who are or may become pregnant during treatment. Women taking estrogen-containing oral contraceptives may be at increased risk of becoming pregnant while on griseofulvin (see also PRECAUTIONS, Drug Interactions ). If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Although no direct causal relationship has been established, spontaneous abortion has been reported rarely coincident with the use of griseofulvin.Note: The Maximum Recommend Human Dose (MRHD) was set at 500 mg/day for the multiple of human exposure calculations performed in this label. If higher doses than 500 mg/day were used clinically, then the multiple of human exposure would be correspondingly reduced for that dose. For example, if a 1,000 mg/day dose was administered to an individual, then the multiple of human exposure would be reduced by a factor of 2.Griseofulvin has been shown to be embryotoxic and teratogenic in pregnant rats when given at a daily oral dose of 250 mg/kg/day [4X the Maximum Recommended Human Dose (MRHD) based on Body Surface Area (BSA)]. Griseofulvin also has been shown to be embryotoxic and teratogenic in pregnant cats treated weekly with griseofulvin at doses of 500 to 1,000 mg/week. There are reports of teratogenicity in a Golden Retriever when doses of 750 mg/day [1.2X the MRHD based on BSA] were administered for four weeks prior to and throughout the pregnancy, and in a study in which beagles were administered 35 mg/kg/day [1.9X the MRHD based on BSA] for intervals from one week up to the entire gestation period. Teratogenicity was also seen in mice when griseofulvin was administered in doses equivalent to 5g/kg/day [40X the MRHD based on BSA] for 2 consecutive days at various stages of the pregnancy.

Regulatory & Marketing

Labeler Name
Heritage Pharmaceuticals Inc D/b/a Avet Pharmaceuticals Inc
Product Type
Human Prescription Drug
FDA Application #
ANDA060569
Marketing Category
ANDA - A product marketed under an approved Abbreviated New Drug Application.
Start Marketing Date
06-30-2023
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.

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Frequently Asked Questions

What is the distribution configuration for this product package?

The code 23155-865-01 identifies a specific commercial package of 100 tablet in 1 bottle, plastic of Griseofulvin Microsize, a human prescription drug labeled by Heritage Pharmaceuticals Inc D/b/a Avet Pharmaceuticals Inc. This tablet is formulated for oral use and contains griseofulvin 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 Heritage Pharmaceuticals Inc D/b/a Avet Pharmaceuticals Inc on June 30, 2023. The current certification is valid through December 31, 2026.

How is this Heritage Pharmaceuticals Inc D/b/a Avet Pharmaceuticals Inc product billed for insurance claims?

For medical billing and reimbursement, this package follows the 11-digit CMS format: 23155086501. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 100 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)
23155-865-01
11-Digit CMS (5-4-2)
23155-0865-01

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