FDA.reportPublic FDA data

Allopurinol

Product NDC
68788-8337
11-digit product format
687888337
Labeler code
68788
Product ID
68788-8337_fd9d90ce-1922-4447-ab20-b2100a1ac263
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA204467
Marketing category
ANDA
Marketing start
2023-01-23
Marketing end
2027-09-29
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol

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
68788-8337-1Allopurinol100 in 1 BOTTLETABLET1004
68788-8337-3Allopurinol30 in 1 BOTTLETABLET304
68788-8337-6Allopurinol60 in 1 BOTTLETABLET604
68788-8337-9Allopurinol90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8337-1EA - Each68788-83370e631e1b-a9c3-4198-9ba3-ac8c65ba06be12023-03-13
68788-8337-3EA - Each68788-8337bc45f9ce-af99-433e-a978-f4f803039d2912023-03-13
68788-8337-6EA - Each68788-83377857ead2-02a4-42e8-a1ec-07accff5f49d12023-03-13
68788-8337-9EA - Each68788-83373ecfaa8a-fa27-4a08-92de-231626377d6412023-03-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8337ALLOPURINOL TABLET [PREFERRED PHARMACEUTICALS INC.]3Current NDC, 4 package rows20250109_6d2f2f76-0f2b-45c4-affe-77bd927df589.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN6d2f2f76-0f2b-45c4-affe-77bd927df5894
197319allopurinol 100 MG Oral TabletSCD6d2f2f76-0f2b-45c4-affe-77bd927df5894

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8337-168788833701100 TABLET in 1 BOTTLE (68788-8337-1) 100 tablet2023-01-232027-09-29NoNoHistorical
68788-8337-36878883370330 TABLET in 1 BOTTLE (68788-8337-3) 30 tablet2023-01-232027-09-29NoNoHistorical
68788-8337-66878883370660 TABLET in 1 BOTTLE (68788-8337-6) 60 tablet2023-01-232027-09-29NoNoHistorical
68788-8337-96878883370990 TABLET in 1 BOTTLE (68788-8337-9) 90 tablet2023-01-232027-09-29NoNoHistorical