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NDC 43063-0393-20 Atovaquone and Proguanil Hydrochloride 250; 100 mg/1; mg/1 Details
Atovaquone and Proguanil Hydrochloride 250; 100 mg/1; mg/1
Atovaquone and Proguanil Hydrochloride is a ORAL TABLET, FILM COATED in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by PD-Rx Pharmaceuticals, Inc.. 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: 43063-0393-20Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Atovaquone and Proguanil
Product Information
| NDC | 43063-0393 |
|---|---|
| Product ID | 43063-393_06447d5e-b13e-7286-e063-6394a90a3dd9 |
| Associated GPIs | 13990002050320 |
| GCN Sequence Number | 045855 |
| GCN Sequence Number Description | atovaquone/proguanil HCl TABLET 250-100 MG ORAL |
| HIC3 | W4A |
| HIC3 Description | ANTIMALARIAL DRUGS |
| GCN | 89891 |
| HICL Sequence Number | 016487 |
| HICL Sequence Number Description | ATOVAQUONE/PROGUANIL HCL |
| Brand/Generic | Generic |
| Proprietary Name | Atovaquone and Proguanil Hydrochloride |
| 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 | 250; 100 |
| Active Ingredient Units | mg/1; mg/1 |
| Substance Name | ATOVAQUONE; PROGUANIL HYDROCHLORIDE |
| Labeler Name | PD-Rx Pharmaceuticals, Inc. |
| Pharmaceutical Class | Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA091211 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 43063-0393-20 (43063039320)
| NDC Package Code | 43063-393-20 |
|---|---|
| Billing NDC | 43063039320 |
| Package | 20 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-393-20) |
| Marketing Start Date | 2012-07-02 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |