Mercaptopurine

Product NDC
0378-3547
11-digit product format
003783547
Labeler code
0378
Product ID
0378-3547_5a3dbd4a-e02f-4ca5-b23f-9e5c62585e9d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mercaptopurine
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA040594
Marketing category
ANDA
Marketing start
2005-07-01
Marketing end
2026-05-31
Substance
MERCAPTOPURINE
Active strength
50 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
No
Current FDA listing
Yes

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf12bc23-c2fc-473d-b96b-09804993250cProduct name220251205
0792acb3-e7e2-462f-964b-46c22a0c6eb5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0378-3547-25Mercaptopurine250 in 1 BOTTLE, PLASTICTABLET25017
0378-3547-52Mercaptopurine25 in 1 BOTTLE, PLASTICTABLET2517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-3547-25EA - Each0378-35470864bfe8-ac28-4c48-b8b3-550c39e1eed812012-07-24
0378-3547-52EA - Each0378-354781224f78-85b8-4c15-bff9-18a420c754d112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MERCAPTOPURINEACTIVE INGREDIENTE7WED276I5MERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7
MERCAPTOPURINE ANHYDROUSACTIVE MOIETYPKK6MUZ20GMERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XMERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30MERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JMERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJMERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0378-3547MERCAPTOPURINE TABLET [MYLAN PHARMACEUTICALS INC.]17Current NDC, Legacy NDC, 2 package rows20250316_15904472-4c32-4224-95d3-eb131a7ff9c8.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-3547-2500378354725250 TABLET in 1 BOTTLE, PLASTIC (0378-3547-25) 250 tablet2005-07-010000-00-00NoNoCurrent
0378-3547-520037835475225 TABLET in 1 BOTTLE, PLASTIC (0378-3547-52) 25 tablet2005-07-012026-05-31NoNoCurrent