FDA.reportPublic FDA data

Allopurinol

Product NDC
71335-9676
11-digit product format
713359676
Labeler code
71335
Product ID
71335-9676_86e949b9-8bbb-4553-94b9-a269765d7d65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA018659
Marketing category
ANDA
Marketing start
1986-10-24
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
71335-9676-1Allopurinol30 in 1 BOTTLETABLET30103
71335-9676-2Allopurinol60 in 1 BOTTLETABLET60103
71335-9676-3Allopurinol100 in 1 BOTTLETABLET100103
71335-9676-4Allopurinol90 in 1 BOTTLETABLET90103
71335-9676-5Allopurinol20 in 1 BOTTLETABLET20103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9676ALLOPURINOL TABLET [BRYANT RANCH PREPACK]102Current NDC, 5 package rows20240406_5dca2d4f-0e93-4d1a-8d9f-b9b72867c242.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN5dca2d4f-0e93-4d1a-8d9f-b9b72867c242103
197320allopurinol 300 MG Oral TabletSCD5dca2d4f-0e93-4d1a-8d9f-b9b72867c242103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9676-17133596760130 TABLET in 1 BOTTLE (71335-9676-1) 30 tablet2024-07-08NoNoHistorical
71335-9676-27133596760260 TABLET in 1 BOTTLE (71335-9676-2) 60 tablet2026-04-13NoNoHistorical
71335-9676-371335967603100 TABLET in 1 BOTTLE (71335-9676-3) 100 tablet2024-03-13NoNoHistorical
71335-9676-47133596760490 TABLET in 1 BOTTLE (71335-9676-4) 90 tablet2023-04-19NoNoHistorical
71335-9676-57133596760520 TABLET in 1 BOTTLE (71335-9676-5) 20 tablet2026-04-13NoNoHistorical