FDA.reportPublic FDA data

Azasan

Product NDC
65649-241
11-digit product format
656490241
Labeler code
65649
Product ID
65649-241_85aaaf8a-26bf-4878-9356-490f17fe65ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Salix Pharmaceuticals
Application
ANDA075252
Marketing category
ANDA
Marketing start
2003-04-01
Substance
AZATHIOPRINE
Active strength
100 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Azasan
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZATHIOPRINE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMRK240IY2L
Rxcui359228, 359229, 404475, 404476

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f4d1a46-20f1-4d12-8172-10a68a29bd37Product name120200714
6675d21e-6399-b5b7-7c97-62806f9c86aaProduct name220200714
e3ccdd15-9c9c-362f-f2a0-79d5e384527fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65649-241-41Azasan100 in 1 BOTTLETABLET10038

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65649-241-41EA - Each65649-241300a9eb5-21e1-44a4-8a0f-6eab170c6cd112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
POVIDONEINACTIVE INGREDIENTFZ989GH94EAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65649-241AZASAN (AZATHIOPRINE) TABLET [SALIX PHARMACEUTICALS]36Current NDC, Legacy NDC, 1 package rows20241019_9050af7a-19c6-4670-937a-9445605de995.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404476AZASAN 100 MG Oral TabletPSN9050af7a-19c6-4670-937a-9445605de99538
404475AZASAN 75 MG Oral TabletPSN9050af7a-19c6-4670-937a-9445605de99538
359228azaTHIOprine 100 MG Oral TabletPSN9050af7a-19c6-4670-937a-9445605de99538
359229azaTHIOprine 75 MG Oral TabletPSN9050af7a-19c6-4670-937a-9445605de99538
404476azathioprine 100 MG Oral Tablet [Azasan]SBD9050af7a-19c6-4670-937a-9445605de99538
404475azathioprine 75 MG Oral Tablet [Azasan]SBD9050af7a-19c6-4670-937a-9445605de99538
359228azathioprine 100 MG Oral TabletSCD9050af7a-19c6-4670-937a-9445605de99538
359229azathioprine 75 MG Oral TabletSCD9050af7a-19c6-4670-937a-9445605de99538
404476Azasan 100 MG Oral TabletSY9050af7a-19c6-4670-937a-9445605de99538
404475Azasan 75 MG Oral TabletSY9050af7a-19c6-4670-937a-9445605de99538

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65649-241-4165649024141100 TABLET in 1 BOTTLE (65649-241-41) 100 tablet2003-04-010000-00-00NoNoCurrent