FDA.reportPublic FDA data

Allopurinol

Product NDC
70518-3704
11-digit product format
705183704
Labeler code
70518
Product ID
70518-3704_4f80384a-8add-7c43-e063-6394a90aebe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA211820
Marketing category
ANDA
Marketing start
2023-04-07
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
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
70518-3704-0Allopurinol30 in 1 BLISTER PACKTABLET307
70518-3704-1Allopurinol100 in 1 BOTTLE, PLASTICTABLET1007
70518-3704-2Allopurinol60 in 1 BOTTLE, PLASTICTABLET607
70518-3704-3Allopurinol90 in 1 BOTTLE, PLASTICTABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3704ALLOPURINOL TABLET [REMEDYREPACK INC.]4Current NDC, 4 package rows20240305_5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f7
197320allopurinol 300 MG Oral TabletSCD5ffcbc32-5996-41cd-acdc-cc4af8cdaf4f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70518-3704-07051837040030 TABLET in 1 BLISTER PACK (70518-3704-0) 30 tablet2023-04-07NoNoHistorical
70518-3704-170518370401100 TABLET in 1 BOTTLE, PLASTIC (70518-3704-1) 100 tablet2024-02-01NoNoHistorical
70518-3704-27051837040260 in 1 BOTTLE, PLASTICHistorical
70518-3704-37051837040390 TABLET in 1 BOTTLE, PLASTIC (70518-3704-3) 90 tablet2025-07-21NoNoHistorical