FDA.reportPublic FDA data

Allopurinol

Product NDC
50090-4662
11-digit product format
500904662
Labeler code
50090
Product ID
50090-4662_2c6ca4a2-0247-41fd-adb9-82bca5e446d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA211820
Marketing category
ANDA
Marketing start
2019-03-12
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ee55bab-4ea8-ac26-c688-380cfbcd5c03Product name720260127
de89a493-168f-43fa-9852-1f15e00dbb17Product name120221110
4a2a34d6-1853-423b-9e0c-360370b95802Product name120171006

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-4662-32023-02-07C16284748780-1f386c64a-0d83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL tablets, for oral use. Initial U.S. Approval:1966
50090-4662-42023-02-07C16284748780-1f386c64a-0d83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL tablets, for oral use. Initial U.S. Approval:1966
50090-4662-32023-01-30C16284748780-1f386c64a-0d83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL tablets, for oral use. Initial U.S. Approval:1966
50090-4662-42023-01-30C16284748780-1f386c64a-0d83-0266-e053-dadaa90a7c1aThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS. ALLOPURINOL tablets, for oral use. Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-4662-3Allopurinol30 in 1 BOTTLETABLET308
50090-4662-4Allopurinol90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4662ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS]8Current NDC, Legacy NDC, 2 package rows20240417_3db4e043-71ff-496a-8087-3fde0e352abf.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN3db4e043-71ff-496a-8087-3fde0e352abf8
197319allopurinol 100 MG Oral TabletSCD3db4e043-71ff-496a-8087-3fde0e352abf8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4662-35009046620330 TABLET in 1 BOTTLE (50090-4662-3) 30 tablet2019-10-290000-00-00NoNoCurrent
50090-4662-45009046620490 TABLET in 1 BOTTLE (50090-4662-4) 90 tablet2019-10-290000-00-00NoNoCurrent