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NDC 00173-0676-01 MALARONE 62.5; 25 mg/1; mg/1 Details
MALARONE 62.5; 25 mg/1; mg/1
MALARONE is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GlaxoSmithKline LLC. The primary component is ATOVAQUONE; PROGUANIL HYDROCHLORIDE.
MedlinePlus Drug Summary
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.
Related Packages: 00173-0676-01Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Atovaquone and Proguanil
Product Information
| NDC | 00173-0676 |
|---|---|
| Product ID | 0173-0676_a4544599-2e43-4fb8-b38d-84613dac6729 |
| Associated GPIs | 13990002050310 |
| GCN Sequence Number | 045854 |
| GCN Sequence Number Description | atovaquone/proguanil HCl TABLET 62.5-25 MG ORAL |
| HIC3 | W4A |
| HIC3 Description | ANTIMALARIAL DRUGS |
| GCN | 89892 |
| HICL Sequence Number | 016487 |
| HICL Sequence Number Description | ATOVAQUONE/PROGUANIL HCL |
| Brand/Generic | Brand |
| Proprietary Name | MALARONE |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | atovaquone and proguanil hydrochloride |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | TABLET, FILM COATED |
| Route | ORAL |
| Active Ingredient Strength | 62.5; 25 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
| Labeler Name | GlaxoSmithKline LLC |
| Pharmaceutical Class | Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA021078 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00173-0676-01 (00173067601)
| NDC Package Code | 0173-0676-01 |
|---|---|
| Billing NDC | 00173067601 |
| Package | 100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01) |
| Marketing Start Date | 2000-07-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |