Pyrimethamine

Product NDC
59651-590
11-digit product format
596510590
Labeler code
59651
Product ID
59651-590_3214e53b-6abb-4a20-b849-0558e79dac05
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Pyrimethamine
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216983
Marketing category
ANDA
Marketing start
2022-10-25
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
Pyrimethamine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PYRIMETHAMINE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiZ3614QOX8W
Rxcui198182

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
59651-590-01Pyrimethamine100 in 1 BOTTLETABLET1002
59651-590-30Pyrimethamine30 in 1 BOTTLETABLET302

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-590-01EA - Each59651-59010646b01-128a-41ce-ad27-2b5a48fa10a012023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-590PYRIMETHAMINE TABLET [AUROBINDO PHARMA LIMITED]2Current NDC, Legacy NDC, 2 package rows20240121_7aca002e-a538-4715-9121-a17bdb7f200c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198182pyrimethamine 25 MG Oral TabletPSN7aca002e-a538-4715-9121-a17bdb7f200c2
198182pyrimethamine 25 MG Oral TabletSCD7aca002e-a538-4715-9121-a17bdb7f200c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-590-0159651059001100 TABLET in 1 BOTTLE (59651-590-01) 100 tablet2022-10-250000-00-00NoNoCurrent
59651-590-305965105903030 TABLET in 1 BOTTLE (59651-590-30) 30 tablet2022-10-250000-00-00NoNoCurrent