FDA.reportPublic FDA data

MALARONE

Product NDC
0173-0676
11-digit product format
001730676
Labeler code
0173
Product ID
0173-0676_39349dbb-ccca-45a2-bc2b-8bd69602d7b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA021078
Marketing category
NDA
Marketing start
2000-07-26
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
MALARONE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE62.5 mg/1
PROGUANIL HYDROCHLORIDE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiR71Y86M0WT, Y883P1Z2LT
Rxcui864675, 864679, 864681, 864685

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4a3a9d58-de64-b317-9153-f2c3fc3a43c9Product name820220517
7beb5026-9819-5e26-fae7-eca2788430deProduct name220150108

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0173-0676-01MALARONE100 in 1 BOTTLETABLET, FILM COATED10030

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0676-01EA - Each0173-0676d95e68f0-c933-4724-a751-56aa90a373da12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
PROGUANIL HYDROCHLORIDEACTIVE INGREDIENTR71Y86M0WTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
ATOVAQUONEACTIVE MOIETYY883P1Z2LTMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
PROGUANILACTIVE MOIETYS61K3P7B2VMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTEDINACTIVE INGREDIENT2165RE0K14MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
POVIDONE K30INACTIVE INGREDIENTU725QWY32XMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPMALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0676MALARONE (ATOVAQUONE AND PROGUANIL HYDROCHLORIDE) TABLET, FILM COATED [GLAXOSMITHKLINE LLC]28Current NDC, Legacy NDC, 1 package rows20240711_fc22e8d8-3bfb-4f70-a599-dd81262a4887.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSNfc22e8d8-3bfb-4f70-a599-dd81262a488730
864681atovaquone 62.5 MG / proguanil HCl 25 MG Oral TabletPSNfc22e8d8-3bfb-4f70-a599-dd81262a488730
864679MALARONE 250 MG / 100 MG Oral TabletPSNfc22e8d8-3bfb-4f70-a599-dd81262a488730
864685MALARONE Pediatric 62.5 MG / 25 MG Oral TabletPSNfc22e8d8-3bfb-4f70-a599-dd81262a488730
864679atovaquone 250 MG / proguanil hydrochloride 100 MG Oral Tablet [Malarone]SBDfc22e8d8-3bfb-4f70-a599-dd81262a488730
864685atovaquone 62.5 MG / proguanil hydrochloride 25 MG Oral Tablet [Malarone]SBDfc22e8d8-3bfb-4f70-a599-dd81262a488730
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCDfc22e8d8-3bfb-4f70-a599-dd81262a488730
864681atovaquone 62.5 MG / proguanil hydrochloride 25 MG Oral TabletSCDfc22e8d8-3bfb-4f70-a599-dd81262a488730
864679Malarone 250/100 (atovaquone / proguanil HCl) Oral TabletSYfc22e8d8-3bfb-4f70-a599-dd81262a488730
864679Malarone 250/100 Oral TabletSYfc22e8d8-3bfb-4f70-a599-dd81262a488730
864685Malarone 62.5/25 (atovaquone / proguanil HCl) Oral TabletSYfc22e8d8-3bfb-4f70-a599-dd81262a488730
864685Malarone 62.5/25 Oral TabletSYfc22e8d8-3bfb-4f70-a599-dd81262a488730

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0173-0676-0100173067601100 TABLET, FILM COATED in 1 BOTTLE (0173-0676-01) 2000-07-260000-00-00NoNoCurrent