FDA.reportPublic FDA data

Allopurinol

Product NDC
71921-240
11-digit product format
719210240
Labeler code
71921
Product ID
71921-240_88cf17e7-9773-490a-992b-63525120cadc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA204467
Marketing category
ANDA
Marketing start
2023-10-31
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, 197320, 245422

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
71921-240-01Allopurinol100 in 1 BOTTLETABLET1005
71921-240-33Allopurinol30 in 1 BOTTLETABLET305
71921-240-50Allopurinol500 in 1 BOTTLETABLET5005
71921-240-60Allopurinol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-240-01EA - Each71921-2406b4cfff1-5f29-4a55-ab67-1b8c9fb2273d12024-01-04
71921-240-50EA - Each71921-2401732d989-3c08-4390-b22c-075b489baac112024-10-04
71921-240-60EA - Each71921-240ac9e729b-915f-490d-ae07-38453af7bbeb12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-240ALLOPURINOL TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]2Current NDC, 4 package rows20231107_815af471-5985-4819-936d-1f5f3d871ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNb943dbb1-7f54-434c-9439-8ce768d94ff4101
197319allopurinol 100 MG Oral TabletSCDb943dbb1-7f54-434c-9439-8ce768d94ff4101
197319allopurinol 100 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
245422allopurinol 200 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
197320allopurinol 300 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
197319allopurinol 100 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
245422allopurinol 200 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
197320allopurinol 300 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
197319allopurinol 100 MG Oral TabletPSN266dbae7-ea4b-7348-e063-6394a90af9ea1
197319allopurinol 100 MG Oral TabletSCD266dbae7-ea4b-7348-e063-6394a90af9ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-240-0171921024001100 TABLET in 1 BOTTLE (71921-240-01) 100 tablet2023-10-31NoNoHistorical
71921-240-337192102403330 TABLET in 1 BOTTLE (71921-240-33) 30 tablet2023-10-31NoNoHistorical
71921-240-5071921024050500 TABLET in 1 BOTTLE (71921-240-50) 500 tablet2023-10-31NoNoHistorical
71921-240-60719210240601000 TABLET in 1 BOTTLE (71921-240-60) 1000 tablet2023-10-31NoNoHistorical