NDC 64679-743 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:
64679-743
Proprietary Name:
Terbinafine Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Wockhardt Usa Llc.
Labeler Code:
64679
Start Marketing Date: [9]
07-02-2007
Listing Expiration Date: [11]
12-31-2022
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
WHITE (C48325)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
W;743
Score:
1

Product Packages

NDC Code 64679-743-01

Package Description: 30 TABLET in 1 BOTTLE

NDC Code 64679-743-02

Package Description: 1000 TABLET in 1 BOTTLE

NDC Code 64679-743-03

Package Description: 100 TABLET in 1 BOTTLE

NDC Code 64679-743-04

Package Description: 10 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK

Product Details

What is NDC 64679-743?

The NDC code 64679-743 is assigned by the FDA to the product Terbinafine Hydrochloride which is product labeled by Wockhardt Usa Llc.. The product's dosage form is . The product is distributed in 4 packages with assigned NDC codes 64679-743-01 30 tablet in 1 bottle , 64679-743-02 1000 tablet in 1 bottle , 64679-743-03 100 tablet in 1 bottle , 64679-743-04 10 blister pack in 1 carton / 10 tablet in 1 blister pack. 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 hydrochloride 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".