FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8364
11-digit product format
687888364
Labeler code
68788
Product ID
68788-8364_8baac3f1-ee0f-4f35-a477-f6138db33936
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204467
Marketing category
ANDA
Marketing start
2023-02-01
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
68788-8364-1Allopurinol100 in 1 BOTTLETABLET1003
68788-8364-3Allopurinol30 in 1 BOTTLETABLET303
68788-8364-9Allopurinol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8364-1EA - Each68788-836457d01fa6-85a3-403a-8b67-3423c2fc574a12023-03-13
68788-8364-3EA - Each68788-83642816cbad-554e-410c-b3c5-0d30fadd30e112023-03-13
68788-8364-9EA - Each68788-8364febc663e-59c5-4c49-b801-0736a115c04e12023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8364ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250119_7f9ad8db-ae68-4a0c-b858-1e727bc98130.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN7f9ad8db-ae68-4a0c-b858-1e727bc981303
197320allopurinol 300 MG Oral TabletSCD7f9ad8db-ae68-4a0c-b858-1e727bc981303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8364-168788836401100 TABLET in 1 BOTTLE (68788-8364-1) 100 tablet2023-02-01NoNoHistorical
68788-8364-36878883640330 TABLET in 1 BOTTLE (68788-8364-3) 30 tablet2023-02-01NoNoHistorical
68788-8364-96878883640990 TABLET in 1 BOTTLE (68788-8364-9) 90 tablet2023-02-01NoNoHistorical