FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8424
11-digit product format
687888424
Labeler code
68788
Product ID
68788-8424_10352740-df97-443c-8991-f9aa5875efed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA018659
Marketing category
ANDA
Marketing start
2023-04-14
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
68788-8424-1Allopurinol100 in 1 BOTTLETABLET1004
68788-8424-3Allopurinol30 in 1 BOTTLETABLET304
68788-8424-9Allopurinol90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8424-1EA - Each68788-84242f928725-78a8-4d25-801b-38eb0fb530b712023-06-06
68788-8424-3EA - Each68788-842447963621-4f83-4273-8970-50347a9abe4d12023-06-06
68788-8424-9EA - Each68788-8424789fbba4-9c99-4cd9-b9f4-496e6c6fff5212023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8424ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 3 package rows20250119_7c7eafa6-5411-470c-8a45-cfbc85d3e335.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN7c7eafa6-5411-470c-8a45-cfbc85d3e3354
197320allopurinol 300 MG Oral TabletSCD7c7eafa6-5411-470c-8a45-cfbc85d3e3354

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8424-168788842401100 TABLET in 1 BOTTLE (68788-8424-1) 100 tablet2023-04-14NoNoHistorical
68788-8424-36878884240330 TABLET in 1 BOTTLE (68788-8424-3) 30 tablet2023-04-14NoNoHistorical
68788-8424-96878884240990 TABLET in 1 BOTTLE (68788-8424-9) 90 tablet2023-04-14NoNoHistorical