NDC 42254-150 Atovaquone And Proguanil Hydrochloride

Product Information

NDC Product Code42254-150
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Atovaquone And Proguanil Hydrochloride
NDC Directory StatusINACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Rebel Distributors Corp
Labeler Code42254
SPL SET ID:0100f9fd-5d4a-4ee6-9c7f-0b60e69e78b8
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
08-18-2011
Listing Expiration Date 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.
12-31-2017
Exclude Flag 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".
I
NDC Code Structure

Product Characteristics

Color(s)PINK (C48328 - PINKISH BROWN TO BROWN)
ShapeROUND (C48348)
Size(s)11 MM
Imprint(s)404;G
Score1

Product Packages

NDC Code 42254-150-16

Package Description: 16 TABLET in 1 BOTTLE

NDC Code 42254-150-24

Package Description: 24 TABLET in 1 BOTTLE

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Product Details

What is NDC 42254-150?

The NDC code 42254-150 is assigned by the FDA to the product Atovaquone And Proguanil Hydrochloride which is product labeled by Rebel Distributors Corp. The product's dosage form is . The product is distributed in 2 packages with assigned NDC codes 42254-150-16 16 tablet in 1 bottle , 42254-150-24 24 tablet in 1 bottle . 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 Atovaquone And Proguanil Hydrochloride?

Prevention of Malaria:Atovaquone and proguanil hydrochloride tablets are indicated for the prophylaxis of P. falciparum malaria, including in areas where chloroquine resistance has been reported (see CLINICAL STUDIES).

Which are Atovaquone And Proguanil Hydrochloride UNII Codes?

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

Which are Atovaquone And Proguanil 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 Atovaquone And Proguanil 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:
  • RxCUI: 864675 - atovaquone 250 MG / proguanil HCl 100 MG Oral Tablet
  • RxCUI: 864675 - atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet

* Please review the disclaimer below.

Product Label

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