FDA.reportPublic FDA data

Azathioprine

Product NDC
65841-602
11-digit product format
658410602
Labeler code
65841
Product ID
65841-602_b1337f9b-c728-4b49-b29a-4f593c100f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA077621
Marketing category
ANDA
Marketing start
2007-07-11
Substance
AZATHIOPRINE
Active strength
50 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
Azathioprine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZATHIOPRINE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMRK240IY2L
Rxcui197388

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
65841-602-01Azathioprine100 in 1 BOTTLETABLET1009
65841-602-05Azathioprine500 in 1 BOTTLETABLET5009

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
POVIDONEINACTIVE INGREDIENTFZ989GH94EAZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZATHIOPRINE TABLET [CADILA HEALTHCARE LIMITED]4
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EAZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZATHIOPRINE ( AZATHIOPRINE ) TABLET [REBEL DISTRIBUTORS CORP..]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-602AZATHIOPRINE TABLET [ZYDUS LIFESCIENCES LIMITED]9Current NDC, Legacy NDC, 2 package rows20241128_d65bc662-2ae8-4ddb-acc8-f616e72e6140.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197388azaTHIOprine 50 MG Oral TabletPSNd65bc662-2ae8-4ddb-acc8-f616e72e61409
197388azathioprine 50 MG Oral TabletSCDd65bc662-2ae8-4ddb-acc8-f616e72e61409
197388azaTHIOprine 50 MG Oral TabletPSN128846a7-18c6-4bc4-b3a0-9aeed0e8b9861
197388azathioprine 50 MG Oral TabletSCD128846a7-18c6-4bc4-b3a0-9aeed0e8b9861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
65841-602-0165841060201100 TABLET in 1 BOTTLE (65841-602-01) 100 tablet2007-07-110000-00-00NoNoCurrent
65841-602-0565841060205500 TABLET in 1 BOTTLE (65841-602-05) 500 tablet2007-07-110000-00-00NoNoCurrent