FDA.reportPublic FDA data

Daraprim

Product NDC
69413-330
11-digit product format
694130330
Labeler code
69413
Product ID
69413-330_ca65359c-029c-44f4-ba89-c4058ddd4e30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyrimethamine
Dosage form
TABLET
Route
ORAL
Labeler
Vyera Pharmaceuticals LLC
Application
NDA008578
Marketing category
NDA
Marketing start
1953-01-23
Substance
PYRIMETHAMINE
Active strength
25 mg/1
Pharmacologic classes
Dihydrofolate Reductase Inhibitor Antimalarial [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
Daraprim
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIMETHAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ3614QOX8W
Rxcui198182, 201912

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
927bc290-af6b-41d8-9ce2-cbb0b8d5cf88Product name320240102

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69413-330-06Daraprim6 in 1 BOTTLE, PLASTICTABLET68
69413-330-10Daraprim100 in 1 BOTTLE, PLASTICTABLET1008
69413-330-30Daraprim30 in 1 BOTTLE, PLASTICTABLET308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69413-330-10EA - Each69413-330a6b9f96b-d49f-4cc7-b1db-d089714ef7ef12016-03-04
69413-330-30EA - Each69413-3302d05ab24-40ce-4a09-bb22-05f154dd67e312016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PYRIMETHAMINEACTIVE INGREDIENTZ3614QOX8WDARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2
PYRIMETHAMINEACTIVE MOIETYZ3614QOX8WDARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GDARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TDARAPRIM (PYRIMETHAMINE) TABLET [TURING PHARMACEUTICALS LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69413-330DARAPRIM (PYRIMETHAMINE) TABLET [VYERA PHARMACEUTICALS LLC]8Current NDC, Legacy NDC, 3 package rows20211202_5368616d-6520-6f6e-2053-686b72656c69.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
201912DARAPRIM 25 MG Oral TabletPSN5368616d-6520-6f6e-2053-686b72656c698
198182pyrimethamine 25 MG Oral TabletPSN5368616d-6520-6f6e-2053-686b72656c698
201912pyrimethamine 25 MG Oral Tablet [Daraprim]SBD5368616d-6520-6f6e-2053-686b72656c698
198182pyrimethamine 25 MG Oral TabletSCD5368616d-6520-6f6e-2053-686b72656c698
201912Daraprim 25 MG Oral TabletSY5368616d-6520-6f6e-2053-686b72656c698
201912DARAPRIM 25 MG Oral TabletPSNf634f34b-0952-4dd3-9da3-f84b6ab823de1
198182pyrimethamine 25 MG Oral TabletPSNf634f34b-0952-4dd3-9da3-f84b6ab823de1
201912pyrimethamine 25 MG Oral Tablet [Daraprim]SBDf634f34b-0952-4dd3-9da3-f84b6ab823de1
198182pyrimethamine 25 MG Oral TabletSCDf634f34b-0952-4dd3-9da3-f84b6ab823de1
201912Daraprim 25 MG Oral TabletSYf634f34b-0952-4dd3-9da3-f84b6ab823de1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69413-330-06694130330066 in 1 BOTTLE, PLASTICHistorical
69413-330-1069413033010100 TABLET in 1 BOTTLE, PLASTIC (69413-330-10) 100 tablet1953-01-230000-00-00NoNoCurrent
69413-330-306941303303030 TABLET in 1 BOTTLE, PLASTIC (69413-330-30) 30 tablet1953-01-230000-00-00NoNoCurrent