NDC 33261-900 Atovaquone And Proguanil 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:
33261-900
Proprietary Name:
Atovaquone And Proguanil Hydrochloride
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Labeler Name: [5]
Aidarex Pharmaceuticals Llc
Labeler Code:
33261
Start Marketing Date: [9]
08-18-2011
Listing Expiration Date: [11]
12-31-2019
Exclude Flag: [12]
I
Code Structure:
Code Navigator:

Product Characteristics

Color(s):
PINK (C48328 - PINKISH BROWN TO BROWN)
Shape:
ROUND (C48348)
Size(s):
11 MM
Imprint(s):
404;G
Score:
1

Product Packages

NDC Code 33261-900-01

Package Description: 24 TABLET, FILM COATED in 1 BLISTER PACK

Product Details

What is NDC 33261-900?

The NDC code 33261-900 is assigned by the FDA to the product Atovaquone And Proguanil Hydrochloride which is product labeled by Aidarex Pharmaceuticals Llc. The product's dosage form is . The product is distributed in a single package with assigned NDC code 33261-900-01 24 tablet, film coated 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 Atovaquone And Proguanil Hydrochloride?

Atovaquone and proguanil hydrochloride is contraindicated in individuals with known hypersensitivity to atovaquone or proguanil hydrochloride or any component of the formulation. Rare cases of anaphylaxis following treatment with atovaquone/proguanil have been reported. Atovaquone and proguanil hydrochloride is contraindicated for prophylaxis of P. falciparum malaria in patients with severe renal impairment (creatinine clearance <30 mL/min) (see CLINICAL PHARMACOLOGY: Special Populations: Renal Impairment).

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

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Patient Education

Atovaquone and Proguanil


The combination of atovaquone and proguanil is used to treat a certain kind of malaria infection (a serious infection that is spread by mosquitoes in certain parts of the world and can cause death) and to prevent a certain kind of malaria infection in travelers who visit areas where malaria is common. Atovaquone and proguanil is in a class of medications called antimalarials. It works by killing the organisms that cause malaria.
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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".