AZATHIOPRINE

Product NDC
16571-835
11-digit product format
165710835
Labeler code
16571
Product ID
16571-835_99588075-8b4a-45ec-90ca-2a23fdd8262a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
ANDA075568
Marketing category
ANDA
Marketing start
2024-06-06
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
16571-835-01AZATHIOPRINE100 in 1 BOTTLETABLET1004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-835-01EA - Each16571-83531d72d37-e96c-4c11-99e7-3e81b393b06412024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-835AZATHIOPRINE TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, 1 package rows20250206_2ffa2fce-895d-469e-8667-b078560aec5f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197388azaTHIOprine 50 MG Oral TabletPSN2ffa2fce-895d-469e-8667-b078560aec5f4
197388azathioprine 50 MG Oral TabletSCD2ffa2fce-895d-469e-8667-b078560aec5f4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
16571-835-0116571083501100 TABLET in 1 BOTTLE (16571-835-01) 100 tablet2024-06-06NoNoCurrent