FDA.reportPublic FDA data

Allopurinol

Product NDC
71335-9634
11-digit product format
713359634
Labeler code
71335
Product ID
71335-9634_4f3457f2-7c67-4d7f-834c-e8ecfc206676
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204467
Marketing category
ANDA
Marketing start
2020-09-22
Marketing end
2029-10-31
Substance
ALLOPURINOL
Active strength
300 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
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
71335-9634-1Allopurinol30 in 1 BOTTLETABLET30104
71335-9634-2Allopurinol60 in 1 BOTTLETABLET60104
71335-9634-3Allopurinol100 in 1 BOTTLETABLET100104
71335-9634-4Allopurinol90 in 1 BOTTLETABLET90104
71335-9634-5Allopurinol20 in 1 BOTTLETABLET20104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9634ALLOPURINOL TABLET [BRYANT RANCH PREPACK]103Current NDC, 5 package rows20240823_30529a62-f95a-40e0-b4c5-2cfc09232068.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN30529a62-f95a-40e0-b4c5-2cfc09232068104
197320allopurinol 300 MG Oral TabletSCD30529a62-f95a-40e0-b4c5-2cfc09232068104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9634-17133596340130 TABLET in 1 BOTTLE (71335-9634-1) 30 tablet2023-03-132029-10-31NoNoHistorical
71335-9634-27133596340260 TABLET in 1 BOTTLE (71335-9634-2) 60 tablet2026-04-152029-10-31NoNoHistorical
71335-9634-371335963403100 TABLET in 1 BOTTLE (71335-9634-3) 100 tablet2024-01-042029-10-31NoNoHistorical
71335-9634-47133596340490 TABLET in 1 BOTTLE (71335-9634-4) 90 tablet2024-04-162029-10-31NoNoHistorical
71335-9634-57133596340520 TABLET in 1 BOTTLE (71335-9634-5) 20 tablet2026-04-152029-10-31NoNoHistorical