FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8713
11-digit product format
687888713
Labeler code
68788
Product ID
68788-8713_b114ca0b-b256-4353-be5a-1a4728fbc090
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214443
Marketing category
ANDA
Marketing start
2024-07-11
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2027-12-31

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
68788-8713-1Allopurinol100 in 1 BOTTLETABLET1003
68788-8713-3Allopurinol330 in 1 BOTTLETABLET3303
68788-8713-9Allopurinol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8713-1EA - Each68788-8713046d0be9-466e-4df8-ae15-6a5dc943d90812024-09-09
68788-8713-3EA - Each68788-8713658a0209-7446-44fd-b173-dfd13a3788a812024-09-09
68788-8713-9EA - Each68788-87136c430788-3fcc-411b-94d4-79bfd6b3a7b912024-09-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8713ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20240727_92d9a9d1-76c0-4435-984d-48f44b452855.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN92d9a9d1-76c0-4435-984d-48f44b4528553
197320allopurinol 300 MG Oral TabletSCD92d9a9d1-76c0-4435-984d-48f44b4528553

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8713-168788871301100 TABLET in 1 BOTTLE (68788-8713-1) 100 tablet2024-07-11NoNoHistorical
68788-8713-368788871303330 TABLET in 1 BOTTLE (68788-8713-3) 330 tablet2024-07-11NoNoHistorical
68788-8713-96878887130990 TABLET in 1 BOTTLE (68788-8713-9) 90 tablet2024-07-11NoNoHistorical