FDA.reportPublic FDA data

Allopurinol

Product NDC
63629-1781
11-digit product format
636291781
Labeler code
63629
Product ID
63629-1781_cf8169e9-905c-44b3-8a4f-14c4f3edfc75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018877
Marketing category
NDA
Marketing start
2009-04-06
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2026-12-31

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
63629-1781-1Allopurinol30 in 1 BOTTLETABLET3013
63629-1781-2Allopurinol60 in 1 BOTTLETABLET6013
63629-1781-3Allopurinol100 in 1 BOTTLETABLET10013
63629-1781-4Allopurinol90 in 1 BOTTLETABLET9013
63629-1781-5Allopurinol20 in 1 BOTTLETABLET2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1781-1EA - Each63629-17816c67b039-6517-4565-b039-23d4cdfd5ae112012-07-24
63629-1781-2EA - Each63629-17819b5528be-f05e-457d-b0fb-2627d2baeb7a12012-07-24
63629-1781-3EA - Each63629-17814b32ab13-2e06-407d-a45a-33eb85dce31412012-07-24
63629-1781-4EA - Each63629-1781bb6558fd-f71a-4b9b-b959-b096c2c2284312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1781ALLOPURINOL TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 5 package rows20240524_7003e410-b4ff-da07-5571-07e7e13f67e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN7003e410-b4ff-da07-5571-07e7e13f67e013
197320allopurinol 300 MG Oral TabletSCD7003e410-b4ff-da07-5571-07e7e13f67e013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1781-16362917810130 TABLET in 1 BOTTLE (63629-1781-1) 30 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-26362917810260 TABLET in 1 BOTTLE (63629-1781-2) 60 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-363629178103100 TABLET in 1 BOTTLE (63629-1781-3) 100 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-46362917810490 TABLET in 1 BOTTLE (63629-1781-4) 90 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-56362917810520 TABLET in 1 BOTTLE (63629-1781-5) 20 tablet2009-04-060000-00-00NoNoCurrent