FDA.reportPublic FDA data

Allopurinol

Product NDC
63187-240
11-digit product format
631870240
Labeler code
63187
Product ID
63187-240_dc8eb4a8-0fb0-4964-9d48-b299f99744f6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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
Rxcui197319, 197320

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
63187-240-30Allopurinol30 in 1 BOTTLE, PLASTICTABLET306
63187-240-60Allopurinol60 in 1 BOTTLE, PLASTICTABLET606
63187-240-90Allopurinol90 in 1 BOTTLE, PLASTICTABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-240-90EA - Each63187-2408acd3092-301a-4fc3-9313-5aba65ffe59912023-04-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [PROFICIENT RX LP]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [PROFICIENT RX LP]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [PROFICIENT RX LP]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-240ALLOPURINOL TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 3 package rows20230225_0ca4baed-c5d8-4de4-ac17-6e5d1df15c03.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197320allopurinol 300 MG Oral TabletPSN0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197319allopurinol 100 MG Oral TabletSCD0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197320allopurinol 300 MG Oral TabletSCD0ca4baed-c5d8-4de4-ac17-6e5d1df15c036

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-240-306318702403030 TABLET in 1 BOTTLE, PLASTIC (63187-240-30) 30 tablet2022-04-010000-00-00NoNoCurrent
63187-240-606318702406060 TABLET in 1 BOTTLE, PLASTIC (63187-240-60) 60 tablet2023-02-22NoNoHistorical
63187-240-906318702409090 TABLET in 1 BOTTLE, PLASTIC (63187-240-90) 90 tablet2023-02-22NoNoHistorical