Allopurinol

Product NDC
65219-380
11-digit product format
652190380
Labeler code
65219
Product ID
65219-380_2d2f4a09-b8bd-47ff-87db-a615efc34c4c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA212363
Marketing category
ANDA
Marketing start
2022-03-14
Substance
ALLOPURINOL SODIUM
Active strength
500 mg/25mL
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
ALLOPURINOL SODIUM500 mg/25mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii428673RC2Z
Rxcui252931

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
65219-380-30Allopurinol25 mL in 1 VIAL, GLASSINJECTION, POWDER, LYOPHILIZED,253
65219-380-30Allopurinol1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-380-30EA - Each65219-38082d96965-33a2-4a18-adeb-42f95b980df912022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65219-380ALLOPURINOL INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [FRESENIUS KABI USA, LLC ]3Current NDC, Legacy NDC, 2 package rows20230204_2caf5eed-2408-4ce0-bd0d-04f4c90e434d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
252931allopurinol sodium 500 MG InjectionPSN2caf5eed-2408-4ce0-bd0d-04f4c90e434d3
252931allopurinol 500 MG InjectionSCD2caf5eed-2408-4ce0-bd0d-04f4c90e434d3
252931allopurinol (as allopurinol sodium) 500 MG InjectionSY2caf5eed-2408-4ce0-bd0d-04f4c90e434d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65219-380-30652190380301 VIAL, GLASS in 1 CARTON (65219-380-30) / 25 mL in 1 VIAL, GLASS2022-03-140000-00-00NoNoCurrent