Allopurinol

Product NDC
80425-0383
11-digit product format
804250383
Labeler code
80425
Product ID
80425-0383_15d70b80-3ae2-bc32-e063-6394a90a163e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA018659
Marketing category
ANDA
Marketing start
2024-04-11
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
Rxcui197320

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
80425-0383-1Allopurinol30 in 1 BOTTLETABLET301
80425-0383-2Allopurinol60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0383-1EA - Each80425-0383a49fe997-4223-4c91-aa8e-115e4004254c12024-05-16
80425-0383-2EA - Each80425-038360d13942-b062-41d5-abb4-9908418f177712024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0383ALLOPURINOL TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 2 package rows20240413_15d758f9-2ec5-ecf5-e063-6394a90a7a2c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN15d758f9-2ec5-ecf5-e063-6394a90a7a2c1
197320allopurinol 300 MG Oral TabletSCD15d758f9-2ec5-ecf5-e063-6394a90a7a2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0383-18042503830130 TABLET in 1 BOTTLE (80425-0383-1) 30 tablet2024-04-11NoNoHistorical
80425-0383-28042503830260 TABLET in 1 BOTTLE (80425-0383-2) 60 tablet2024-04-11NoNoHistorical