FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8458
11-digit product format
687888458
Labeler code
68788
Product ID
68788-8458_92bc61cd-b263-4e1a-8387-f82b295df68b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA211820
Marketing category
ANDA
Marketing start
2023-06-14
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
68788-8458-1Allopurinol100 in 1 BOTTLE, PLASTICTABLET1004
68788-8458-3Allopurinol30 in 1 BOTTLE, PLASTICTABLET304
68788-8458-6Allopurinol60 in 1 BOTTLE, PLASTICTABLET604
68788-8458-9Allopurinol90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8458-1EA - Each68788-8458efa7e2e5-3564-42eb-b192-3d013ccc75a112023-07-06
68788-8458-3EA - Each68788-845897a533bb-6b78-4b23-9df0-8d02d60a682a12023-07-06
68788-8458-6EA - Each68788-8458c1c244a4-f768-4ed5-bc8c-8991321faebc12023-07-06
68788-8458-9EA - Each68788-845864912ae3-e449-41aa-ae80-400776dac7c612023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8458ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250109_e11e94b9-d897-48ce-9a80-aa6b8b5fde02.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNe11e94b9-d897-48ce-9a80-aa6b8b5fde024
197319allopurinol 100 MG Oral TabletSCDe11e94b9-d897-48ce-9a80-aa6b8b5fde024

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8458-168788845801100 TABLET in 1 BOTTLE, PLASTIC (68788-8458-1) 100 tablet2023-06-14NoNoHistorical
68788-8458-36878884580330 TABLET in 1 BOTTLE, PLASTIC (68788-8458-3) 30 tablet2023-06-14NoNoHistorical
68788-8458-66878884580660 TABLET in 1 BOTTLE, PLASTIC (68788-8458-6) 60 tablet2023-06-14NoNoHistorical
68788-8458-96878884580990 TABLET in 1 BOTTLE, PLASTIC (68788-8458-9) 90 tablet2023-06-14NoNoHistorical