FDA.reportPublic FDA data

IMURAN

Product NDC
65483-590
11-digit product format
654830590
Labeler code
65483
Product ID
65483-590_52d9d9c5-cb11-4901-ab91-bc03805af972
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Prometheus Laboratories Inc.
Application
NDA016324
Marketing category
NDA
Marketing start
1968-03-20
Marketing end
0000-00-00
Substance
AZATHIOPRINE
Active strength
50 mg/1
Pharmacologic classes
Nucleoside Analog [EXT],Purine Antimetabolite [EPC],Purines [CS],Nucleic Acid Synthesis Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65483-590-102020-01-31C16284748780-19d75b9d0-de67-f424-e053-dadaa90a57ceIMURAN ® (azathioprine) 50-mg Scored Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65483-590-10IMURAN100 in 1 BOTTLETABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65483-590-10EA - Each65483-5901a9ed699-f169-447e-81a2-24ae511418c212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
azathioprineACTIVE INGREDIENTMRK240IY2LIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
azathioprineACTIVE MOIETYMRK240IY2LIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
lactoseINACTIVE INGREDIENTJ2B2A4N98GIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
magnesium stearateINACTIVE INGREDIENT70097M6I30IMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
povidoneINACTIVE INGREDIENTFZ989GH94EIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
starch, potatoINACTIVE INGREDIENT8I089SAH3TIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11
stearic acidINACTIVE INGREDIENT4ELV7Z65APIMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65483-590IMURAN (AZATHIOPRINE) TABLET [PROMETHEUS LABORATORIES INC.]11Legacy NDC, 1 package rows20150330_aaa6c540-4c84-48a0-939c-cd423134fa2a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197388azaTHIOprine 50 MG Oral TabletPSNaaa6c540-4c84-48a0-939c-cd423134fa2a11
105611IMURAN 50 MG Oral TabletPSNaaa6c540-4c84-48a0-939c-cd423134fa2a11
105611azathioprine 50 MG Oral Tablet [Imuran]SBDaaa6c540-4c84-48a0-939c-cd423134fa2a11
197388azathioprine 50 MG Oral TabletSCDaaa6c540-4c84-48a0-939c-cd423134fa2a11
105611Imuran 50 MG Oral TabletSYaaa6c540-4c84-48a0-939c-cd423134fa2a11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
65483-590-1065483059010100 in 1 BOTTLEHistorical