FDA.reportPublic FDA data

Azathioprine

Product NDC
67877-492
11-digit product format
678770492
Labeler code
67877
Product ID
67877-492_7fdec2f6-c3b5-483f-8bfc-0afb292781da
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA208687
Marketing category
ANDA
Marketing start
2020-03-29
Substance
AZATHIOPRINE
Active strength
25 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
AZATHIOPRINE25 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
67877-492-01Azathioprine100 in 1 BOTTLETABLET1009
67877-492-05Azathioprine500 in 1 BOTTLETABLET5009
67877-492-10Azathioprine1000 in 1 BOTTLETABLET10009
67877-492-14Azathioprine14 in 1 BLISTER PACKTABLET149
67877-492-14Azathioprine1 in 1 CARTONTABLET19
67877-492-33Azathioprine10 in 1 BLISTER PACKTABLET109
67877-492-38Azathioprine10 in 1 CARTONTABLET109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-492AZATHIOPRINE TABLET [ASCEND LABORATORIES, LLC]9Current NDC, Legacy NDC, 7 package rows20250425_bc6dc4bd-2121-4613-9d90-4a504010c98a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
359228azaTHIOprine 100 MG Oral TabletPSNbc6dc4bd-2121-4613-9d90-4a504010c98a9
199310azaTHIOprine 25 MG Oral TabletPSNbc6dc4bd-2121-4613-9d90-4a504010c98a9
197388azaTHIOprine 50 MG Oral TabletPSNbc6dc4bd-2121-4613-9d90-4a504010c98a9
359229azaTHIOprine 75 MG Oral TabletPSNbc6dc4bd-2121-4613-9d90-4a504010c98a9
359228azathioprine 100 MG Oral TabletSCDbc6dc4bd-2121-4613-9d90-4a504010c98a9
199310azathioprine 25 MG Oral TabletSCDbc6dc4bd-2121-4613-9d90-4a504010c98a9
197388azathioprine 50 MG Oral TabletSCDbc6dc4bd-2121-4613-9d90-4a504010c98a9
359229azathioprine 75 MG Oral TabletSCDbc6dc4bd-2121-4613-9d90-4a504010c98a9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-492-0167877049201100 TABLET in 1 BOTTLE (67877-492-01) 100 tablet2020-03-290000-00-00NoNoCurrent
67877-492-0567877049205500 TABLET in 1 BOTTLE (67877-492-05) 500 tablet2020-03-290000-00-00NoNoCurrent
67877-492-10678770492101000 TABLET in 1 BOTTLE (67877-492-10) 1000 tablet2020-03-290000-00-00NoNoCurrent
67877-492-14678770492141 BLISTER PACK in 1 CARTON (67877-492-14) / 14 TABLET in 1 BLISTER PACK1 blister pack2020-03-290000-00-00NoNoCurrent
67877-492-336787704923310 in 1 BLISTER PACKHistorical
67877-492-386787704923810 BLISTER PACK in 1 CARTON (67877-492-38) / 10 TABLET in 1 BLISTER PACK (67877-492-33) 10 blister pack2020-03-290000-00-00NoNoCurrent