Home NDC 68462-402 Atovaquone and Proguanil Hydrochloride Pediatric
Product NDC 68462-402
11-digit product format 684620402
Labeler code 68462
Product ID 68462-402_a6232b89-d1c0-4114-879d-6c9320a92eb2
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Atovaquone and Proguanil Hydrochloride Pediatric
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Glenmark Pharmaceuticals Inc.,USA
Application ANDA091211
Marketing category ANDA
Marketing start 2015-04-08
Substance ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength 62.5; 25 mg/1; mg/1
Pharmacologic classes Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Atovaquone and Proguanil Hydrochloride Pediatric
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ATOVAQUONE 62.5 mg/1 PROGUANIL HYDROCHLORIDE 25 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii R71Y86M0WT, Y883P1Z2LT Rxcui 864675, 864681
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68462-402-01 Atovaquone and Proguanil Hydrochloride Pediatric 100 in 1 BOTTLE TABLET, FILM COATED 100 14 68462-402-30 Atovaquone and Proguanil Hydrochloride Pediatric 30 in 1 BOTTLE TABLET, FILM COATED 30 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded ATOVAQUONE ACTIVE INGREDIENT Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 PROGUANIL HYDROCHLORIDE ACTIVE INGREDIENT R71Y86M0WT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 ATOVAQUONE ACTIVE MOIETY Y883P1Z2LT ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 PROGUANIL ACTIVE MOIETY S61K3P7B2V ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 FERRIC OXIDE RED INACTIVE INGREDIENT 1K09F3G675 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED INACTIVE INGREDIENT 2165RE0K14 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 HYPROMELLOSE 2910 (15 MPA.S) INACTIVE INGREDIENT 36SFW2JZ0W ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 POVIDONE K30 INACTIVE INGREDIENT U725QWY32X ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 SILICON DIOXIDE INACTIVE INGREDIENT ETJ7Z6XBU4 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 SODIUM STARCH GLYCOLATE TYPE A POTATO INACTIVE INGREDIENT 5856J3G2A2 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68462-402 ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED ATOVAQUONE AND PROGUANIL HYDROCHLORIDE PEDIATRIC TABLET, FILM COATED [GLENMARK PHARMACEUTICALS INC.,USA] 12 Current NDC, Legacy NDC, 2 package rows 20230111_4b80d087-eaa7-448f-967e-344de7f16436.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 68462-402-01 68462040201 100 TABLET, FILM COATED in 1 BOTTLE (68462-402-01) 2015-04-08 0000-00-00 No No Current 68462-402-30 68462040230 30 in 1 BOTTLE Historical