Allopurinol

Product NDC
43353-186
11-digit product format
433530186
Labeler code
43353
Product ID
43353-186_8b90efb6-87d0-428c-b0ef-13237a009714
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA018659
Marketing category
ANDA
Marketing start
1986-10-24
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-186-60Allopurinol90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-186ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]3Current NDC, Legacy NDC, 1 package rows20171011_aea483a7-4ce7-4fe5-936c-fd876b4fa3a8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSNaea483a7-4ce7-4fe5-936c-fd876b4fa3a83
197320allopurinol 300 MG Oral TabletSCDaea483a7-4ce7-4fe5-936c-fd876b4fa3a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-186-604335301866090 TABLET in 1 BOTTLE (43353-186-60) 90 tablet2016-06-170000-00-00NoNoCurrent