FDA.reportPublic FDA data

Atovaquone and Proguanil Hydrochloride

Product NDC
51407-869
11-digit product format
514070869
Labeler code
51407
Product ID
51407-869_45b153c9-e06e-468c-e063-6294a90a2938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
atovaquone and proguanil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA202362
Marketing category
ANDA
Marketing start
2014-05-27
Substance
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
Active strength
250; 100 mg/1; mg/1
Pharmacologic classes
Antimalarial [EPC], Antimalarial [EPC], Antiprotozoal [EPC], Dihydrofolate Reductase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Atovaquone and Proguanil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ATOVAQUONE250 mg/1
PROGUANIL HYDROCHLORIDE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiY883P1Z2LT, R71Y86M0WT
Rxcui864675

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
51407-869-01Atovaquone and Proguanil Hydrochloride100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1002
51407-869-24Atovaquone and Proguanil Hydrochloride24 in 1 BOTTLE, PLASTICTABLET, FILM COATED242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-869-01EA - Each51407-869051ad86e-226d-4cec-8578-c28e3938ec2d12024-05-16
51407-869-24EA - Each51407-8699886d77b-d470-4d89-bfb5-44647b2c0c1b12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-869ATOVAQUONE AND PROGUANIL HYDROCHLORIDE TABLET, FILM COATED [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 2 package rows20240404_152433eb-1341-9cc0-e063-6394a90a1481.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
864675atovaquone 250 MG / proguanil HCl 100 MG Oral TabletPSN152433eb-1341-9cc0-e063-6394a90a14812
864675atovaquone 250 MG / proguanil hydrochloride 100 MG Oral TabletSCD152433eb-1341-9cc0-e063-6394a90a14812

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-869-0151407086901100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-01) 2024-04-02NoNoHistorical
51407-869-245140708692424 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51407-869-24) 2024-04-02NoNoHistorical