Azathioprine

Product NDC
68382-119
11-digit product format
683820119
Labeler code
68382
Product ID
68382-119_64e1751f-fdf5-45e7-ac57-6499c0b5aa91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA077621
Marketing category
ANDA
Marketing start
2017-12-02
Substance
AZATHIOPRINE
Active strength
75 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
AZATHIOPRINE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMRK240IY2L
Rxcui197388, 199310, 359228, 359229

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
68382-119-01Azathioprine100 in 1 BOTTLETABLET10011
68382-119-05Azathioprine500 in 1 BOTTLETABLET50011
68382-119-01Azathioprine100 in 1 BOTTLETABLET1006
68382-119-05Azathioprine500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-119-01EA - Each68382-11965e775c1-0bd3-4d3a-b89d-4276ff05ddd512021-11-09

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
POVIDONEINACTIVE INGREDIENTFZ989GH94EAZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-119AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]11Current NDC, Legacy NDC, 2 package rows20240811_b1b0fa3e-11c3-46d0-9537-6b372c2a1b56.zip
68382-119AZATHIOPRINE TABLET [ZYDUS PHARMACEUTICALS USA INC.]6Current NDC, Legacy NDC, 2 package rows20230917_1cd03d78-d567-4449-be98-0e8652ceff6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359228azaTHIOprine 100 MG Oral TabletPSNb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
199310azaTHIOprine 25 MG Oral TabletPSNb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
197388azaTHIOprine 50 MG Oral TabletPSNb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
359229azaTHIOprine 75 MG Oral TabletPSNb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
359228azathioprine 100 MG Oral TabletSCDb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
199310azathioprine 25 MG Oral TabletSCDb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
197388azathioprine 50 MG Oral TabletSCDb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
359229azathioprine 75 MG Oral TabletSCDb1b0fa3e-11c3-46d0-9537-6b372c2a1b5611
359228azaTHIOprine 100 MG Oral TabletPSN1cd03d78-d567-4449-be98-0e8652ceff6a6
199310azaTHIOprine 25 MG Oral TabletPSN1cd03d78-d567-4449-be98-0e8652ceff6a6
359229azaTHIOprine 75 MG Oral TabletPSN1cd03d78-d567-4449-be98-0e8652ceff6a6
359228azathioprine 100 MG Oral TabletSCD1cd03d78-d567-4449-be98-0e8652ceff6a6
199310azathioprine 25 MG Oral TabletSCD1cd03d78-d567-4449-be98-0e8652ceff6a6
359229azathioprine 75 MG Oral TabletSCD1cd03d78-d567-4449-be98-0e8652ceff6a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68382-119-0168382011901100 TABLET in 1 BOTTLE (68382-119-01) 100 tablet2017-12-020000-00-00NoNoCurrent
68382-119-0568382011905500 TABLET in 1 BOTTLE (68382-119-05) 500 tablet2017-12-020000-00-00NoNoCurrent