FDA.reportPublic FDA data

Allopurinol

Product NDC
71921-242
11-digit product format
719210242
Labeler code
71921
Product ID
71921-242_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
300 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
ALLOPURINOL300 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
71921-242-01Allopurinol100 in 1 BOTTLETABLET1005
71921-242-50Allopurinol500 in 1 BOTTLETABLET5005
71921-242-60Allopurinol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-242-01EA - Each71921-242d06f7ce1-3fae-4902-8cc8-65aae8ba70e512024-01-04
71921-242-50EA - Each71921-242f9624697-76e7-4011-a419-c3166026b2d812024-06-10
71921-242-60EA - Each71921-242067a4931-dfc0-46bb-a5ec-b21918bb8da712025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-242ALLOPURINOL TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]2Current NDC, 3 package rows20231107_815af471-5985-4819-936d-1f5f3d871ef8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
197320allopurinol 300 MG Oral TabletPSN4a00a35a-cc85-0088-e063-6394a90a07442
197320allopurinol 300 MG Oral TabletSCD4a00a35a-cc85-0088-e063-6394a90a07442
197320allopurinol 300 MG Oral TabletPSN4f5c4fbc-3d31-5068-e063-6294a90ab3151
197320allopurinol 300 MG Oral TabletSCD4f5c4fbc-3d31-5068-e063-6294a90ab3151

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-242-0171921024201100 TABLET in 1 BOTTLE (71921-242-01) 100 tablet2023-10-31NoNoHistorical
71921-242-5071921024250500 TABLET in 1 BOTTLE (71921-242-50) 500 tablet2023-10-31NoNoHistorical
71921-242-60719210242601000 TABLET in 1 BOTTLE (71921-242-60) 1000 tablet2023-10-31NoNoHistorical