FDA.reportPublic FDA data

Allopurinol

Product NDC
71335-9641
11-digit product format
713359641
Labeler code
71335
Product ID
71335-9641_bbbe44c2-d66c-40c2-9da1-3326cb9aeae5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211820
Marketing category
ANDA
Marketing start
2019-03-12
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
71335-9641-1Allopurinol100 in 1 BOTTLE, PLASTICTABLET100103
71335-9641-2Allopurinol30 in 1 BOTTLE, PLASTICTABLET30103
71335-9641-3Allopurinol60 in 1 BOTTLE, PLASTICTABLET60103
71335-9641-4Allopurinol120 in 1 BOTTLE, PLASTICTABLET120103
71335-9641-5Allopurinol20 in 1 BOTTLE, PLASTICTABLET20103
71335-9641-6Allopurinol90 in 1 BOTTLE, PLASTICTABLET90103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9641ALLOPURINOL TABLET [BRYANT RANCH PREPACK]102Current NDC, 6 package rows20240407_8ae2d634-df53-40a8-a6bd-6fee7dacd754.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN8ae2d634-df53-40a8-a6bd-6fee7dacd754103
197319allopurinol 100 MG Oral TabletSCD8ae2d634-df53-40a8-a6bd-6fee7dacd754103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9641-171335964101100 TABLET in 1 BOTTLE, PLASTIC (71335-9641-1) 100 tablet2023-09-06NoNoHistorical
71335-9641-27133596410230 TABLET in 1 BOTTLE, PLASTIC (71335-9641-2) 30 tablet2023-02-14NoNoHistorical
71335-9641-37133596410360 TABLET in 1 BOTTLE, PLASTIC (71335-9641-3) 60 tablet2023-12-11NoNoHistorical
71335-9641-471335964104120 TABLET in 1 BOTTLE, PLASTIC (71335-9641-4) 120 tablet2026-04-15NoNoHistorical
71335-9641-57133596410520 TABLET in 1 BOTTLE, PLASTIC (71335-9641-5) 20 tablet2026-04-15NoNoHistorical
71335-9641-67133596410690 TABLET in 1 BOTTLE, PLASTIC (71335-9641-6) 90 tablet2023-03-03NoNoHistorical