FDA.reportPublic FDA data

Allopurinol

Product NDC
50090-4663
11-digit product format
500904663
Labeler code
50090
Product ID
50090-4663_4da63803-9e71-4b39-aa85-290e989cd229
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
300 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
ALLOPURINOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197320

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
50090-4663-02023-10-31C16284748780-1f386c649-f649-0266-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
50090-4663-12023-10-31C16284748780-1f386c649-f649-0266-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
50090-4663-32023-10-31C16284748780-1f386c649-f649-0266-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
50090-4663-02023-01-30C16284748780-1f386c649-f649-0266-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
50090-4663-12023-01-30C16284748780-1f386c649-f649-0266-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
50090-4663-32023-01-30C16284748780-1f386c649-f649-0266-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
50090-4663-0Allopurinol100 in 1 BOTTLETABLET1009
50090-4663-1Allopurinol30 in 1 BOTTLETABLET309
50090-4663-3Allopurinol90 in 1 BOTTLETABLET909

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-4663ALLOPURINOL TABLET [A-S MEDICATION SOLUTIONS]9Current NDC, Legacy NDC, 3 package rows20240417_2caa5246-9422-4826-b926-a2566506d3eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN2caa5246-9422-4826-b926-a2566506d3eb9
197320allopurinol 300 MG Oral TabletSCD2caa5246-9422-4826-b926-a2566506d3eb9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-4663-050090466300100 TABLET in 1 BOTTLE (50090-4663-0) 100 tablet2019-10-290000-00-00NoNoCurrent
50090-4663-15009046630130 TABLET in 1 BOTTLE (50090-4663-1) 30 tablet2019-10-290000-00-00NoNoCurrent
50090-4663-35009046630390 TABLET in 1 BOTTLE (50090-4663-3) 90 tablet2019-10-290000-00-00NoNoCurrent