FDA.reportPublic FDA data

MEPRON

Product NDC
0173-0665
11-digit product format
001730665
Labeler code
0173
Product ID
0173-0665_568047d4-1669-4c16-bbd0-d242a6b91507
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone
Dosage form
SUSPENSION
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA020500
Marketing category
NDA
Marketing start
1995-02-28
Substance
ATOVAQUONE
Active strength
750 mg/5mL
Pharmacologic classes
Antimalarial [EPC], Antiprotozoal [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
MEPRON
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE750 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY883P1Z2LT
Rxcui211947, 308429

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
0173-0665-18MEPRON210 mL in 1 BOTTLESUSPENSION21027

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0665-18ML - Milliliter0173-066596a2530d-2d87-4a7e-99bf-0d702188681d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ATOVAQUONEACTIVE INGREDIENTY883P1Z2LTMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
ATOVAQUONEACTIVE MOIETYY883P1Z2LTMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
WATERINACTIVE INGREDIENT059QF0KO0RMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEMEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0173-0665MEPRON (ATOVAQUONE) SUSPENSION [GLAXOSMITHKLINE LLC]25Current NDC, Legacy NDC, 1 package rows20240711_b426b6bf-f07e-4580-97ae-dfca1ddf5b8f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308429atovaquone 750 MG in 5 mL Oral SuspensionPSNb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
211947MEPRON 750 MG in 5 mL Oral SuspensionPSNb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
211947atovaquone 150 MG/ML Oral Suspension [Mepron]SBDb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
308429atovaquone 150 MG/ML Oral SuspensionSCDb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
308429atovaquone 1500 MG per 10 ML Oral SuspensionSYb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
308429atovaquone 750 MG per 5 ML Oral SuspensionSYb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
211947Mepron 150 MG/ML Oral SuspensionSYb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27
211947Mepron 750 MG per 5 ML Oral SuspensionSYb426b6bf-f07e-4580-97ae-dfca1ddf5b8f27

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0665-1800173066518210 mL in 1 BOTTLE (0173-0665-18) 210 ml1995-02-280000-00-00NoNoCurrent