NDC 42043-410 Terbinafine Hydrochloride

View Dosage, Usage, Ingredients, Routes, UNII

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.
NDC Product Code:
42043-410
Proprietary Name:
Terbinafine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Orchidpharma Inc
Labeler Code:
42043
Start Marketing Date: [9]
10-01-2020
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - LIGHT PINK)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
501
Score:
1

Product Packages

NDC Code 42043-410-01

Package Description: 100 TABLET in 1 BOTTLE, PLASTIC

Price per Unit: $0.15129 per EA

NDC Code 42043-410-03

Package Description: 30 TABLET in 1 BOTTLE, PLASTIC

Price per Unit: $0.15129 per EA

Product Details

What is NDC 42043-410?

The NDC code 42043-410 is assigned by the FDA to the product Terbinafine Hydrochloride which is product labeled by Orchidpharma Inc. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 42043-410-01 100 tablet in 1 bottle, plastic , 42043-410-03 30 tablet in 1 bottle, plastic . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

What are the uses for Terbinafine Hydrochloride?

Terbinafine tablets are indicated for the treatment of onychomycosis of the toenail or fingernail due to dermatophytes (tinea unguium).Prior to initiating treatment, appropriate nail specimens for laboratory testing [potassium hydroxide (KOH) preparation, fungal culture, or nail biopsy] should be obtained to confirm the diagnosis of onychomycosis.

Which are Terbinafine Hydrochloride UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are Terbinafine Hydrochloride Inactive Ingredients UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for Terbinafine Hydrochloride?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:

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Patient Education

Terbinafine


Terbinafine granules are used to treat fungal infections of the scalp. Terbinafine tablets are used to treat fungal infections of the toenails and fingernails. Terbinafine is in a class of medications called antifungals. It works by stopping the growth of fungi.
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Product Footnotes

[5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

[9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

[11] What is the Listing Expiration Date? - This is the date when the listing record will expire if not updated or certified by the product labeler.

[12] What is the NDC Exclude Flag? - This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".