FDA.reportPublic FDA data

Daraprim

Product NDC
83649-330
11-digit product format
836490330
Labeler code
83649
Product ID
83649-330_c7c0666e-57ea-45e4-b3b4-e3950a173011
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pyrimethamine
Dosage form
TABLET
Route
ORAL
Labeler
TILDE Sciences 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
83649-330-01Daraprim100 in 1 BOTTLE, PLASTICTABLET1001
83649-330-03Daraprim30 in 1 BOTTLE, PLASTICTABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83649-330-01EA - Each83649-330bf5998e1-71e7-4f8e-b657-97314c88d15512024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83649-330DARAPRIM (PYRIMETHAMINE) TABLET [TILDE SCIENCES LLC]1Current NDC, 2 package rows20231209_f634f34b-0952-4dd3-9da3-f84b6ab823de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
83649-330-0183649033001100 TABLET in 1 BOTTLE, PLASTIC (83649-330-01) 100 tablet2023-12-12NoNoCurrent
83649-330-038364903300330 TABLET in 1 BOTTLE, PLASTIC (83649-330-03) 30 tablet2023-12-12NoNoCurrent