FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8727
11-digit product format
687888727
Labeler code
68788
Product ID
68788-8727_03bd7df3-040e-4ebc-a3af-ed4d8ec66c91
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA214443
Marketing category
ANDA
Marketing start
2024-08-16
Substance
ALLOPURINOL
Active strength
100 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
ALLOPURINOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319

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
68788-8727-1Allopurinol100 in 1 BOTTLETABLET1003
68788-8727-3Allopurinol30 in 1 BOTTLETABLET303
68788-8727-6Allopurinol60 in 1 BOTTLETABLET603
68788-8727-9Allopurinol90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8727-1EA - Each68788-8727bc0c9c5f-c4f3-4d06-8bee-d07b1ca4ecc312024-10-04
68788-8727-3EA - Each68788-872791c2c6c2-2012-49f4-91aa-156b8869f84812024-10-04
68788-8727-6EA - Each68788-872794c227d2-8b0e-4e55-8507-5d5e87c7cbb612024-10-04
68788-8727-9EA - Each68788-87276eea5800-2a9e-4840-ae95-fdd81c0d8b1612024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8727ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 4 package rows20240820_b3b9dcf4-cada-4f79-befc-319c7dff15eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNb3b9dcf4-cada-4f79-befc-319c7dff15eb3
197319allopurinol 100 MG Oral TabletSCDb3b9dcf4-cada-4f79-befc-319c7dff15eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8727-168788872701100 TABLET in 1 BOTTLE (68788-8727-1) 100 tablet2024-08-16NoNoHistorical
68788-8727-36878887270330 TABLET in 1 BOTTLE (68788-8727-3) 30 tablet2024-08-16NoNoHistorical
68788-8727-66878887270660 TABLET in 1 BOTTLE (68788-8727-6) 60 tablet2024-08-16NoNoHistorical
68788-8727-96878887270990 TABLET in 1 BOTTLE (68788-8727-9) 90 tablet2024-08-16NoNoHistorical