FDA.reportPublic FDA data

ALLOPURINOL

Product NDC
72865-303
11-digit product format
728650303
Labeler code
72865
Product ID
72865-303_47dd9bd8-06e7-b387-e063-6294a90a74d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
XLCare Pharmaceuticals Inc.
Application
ANDA217748
Marketing category
ANDA
Marketing start
2026-01-08
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

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
72865-303-01ALLOPURINOL100 in 1 BOTTLETABLET1001
72865-303-05ALLOPURINOL500 in 1 BOTTLETABLET5001
72865-303-10ALLOPURINOL1000 in 1 BOTTLETABLET10001
72865-303-90ALLOPURINOL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72865-303-01EA - Each72865-303ed36324f-3778-4f97-92ee-ab22e8b0198812026-04-20
72865-303-10EA - Each72865-30333c4d565-27c1-42c0-aeb2-b64fda18d76312026-04-20

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNfc7973c8-d846-4eca-ab0d-d30228035ba21
197320allopurinol 300 MG Oral TabletPSNfc7973c8-d846-4eca-ab0d-d30228035ba21
197319allopurinol 100 MG Oral TabletSCDfc7973c8-d846-4eca-ab0d-d30228035ba21
197320allopurinol 300 MG Oral TabletSCDfc7973c8-d846-4eca-ab0d-d30228035ba21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72865-303-0172865030301100 TABLET in 1 BOTTLE (72865-303-01) 100 tablet2026-01-08NoNoCurrent
72865-303-0572865030305500 TABLET in 1 BOTTLE (72865-303-05) 500 tablet2026-01-08NoNoCurrent
72865-303-10728650303101000 TABLET in 1 BOTTLE (72865-303-10) 1000 tablet2026-01-08NoNoCurrent
72865-303-907286503039090 TABLET in 1 BOTTLE (72865-303-90) 90 tablet2026-01-08NoNoCurrent