Atovaquone and Proguanil HCl
These highlights do not include all the information needed to use Atovaquone and Proguanil Hydrochloride safely and effectively. See full prescribing information for Atovaquone and Proguanil Hydrochloride. Atovaquone and Proguanil Hydrochloride tabletsInitial U.S. Approval: 2000
Approved
Approval ID
7069521a-c7f9-4e8d-99b8-0cb5c971e7cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 6, 2022
Manufacturers
FDA
Prasco Laboratories
DUNS: 065969375
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
atovaquone and proguanil hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66993-060
Application NumberNDA021078
Product Classification
M
Marketing Category
C73605
G
Generic Name
atovaquone and proguanil hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 2, 2021
FDA Product Classification
INGREDIENTS (13)
LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIEDInactive
Code: 2165RE0K14
Classification: IACT
ATOVAQUONEActive
Quantity: 250 mg in 1 1
Code: Y883P1Z2LT
Classification: ACTIB
PROGUANIL HYDROCHLORIDEActive
Quantity: 100 mg in 1 1
Code: R71Y86M0WT
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POLOXAMER 188Inactive
Code: LQA7B6G8JG
Classification: IACT
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT