FDA.reportPublic FDA data

Allopurinol

Product NDC
71335-0112
11-digit product format
713350112
Labeler code
71335
Product ID
71335-0112_413f5522-202b-43ab-8ffe-f9e9f5c52ab2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203154
Marketing category
ANDA
Marketing start
2015-04-29
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
71335-0112-1Allopurinol30 in 1 BOTTLETABLET3013
71335-0112-2Allopurinol60 in 1 BOTTLETABLET6013
71335-0112-3Allopurinol100 in 1 BOTTLETABLET10013
71335-0112-4Allopurinol90 in 1 BOTTLETABLET9013
71335-0112-5Allopurinol20 in 1 BOTTLETABLET2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-0112-1EA - Each71335-0112b964f860-6b39-4f25-bf51-46178b3aad2212018-03-08
71335-0112-2EA - Each71335-01121294ca18-454e-428e-bf33-e4bdd300747c12018-03-08
71335-0112-3EA - Each71335-01121141ed87-16cd-4faf-ad13-70fb9a5f3a7c12018-03-08
71335-0112-4EA - Each71335-011210c1488f-8d31-4882-9e28-99160ddababb12018-03-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-0112ALLOPURINOL TABLET [BRYANT RANCH PREPACK]12Current NDC, Legacy NDC, 5 package rows20240509_76ed9122-b845-423b-a6d5-a47b31743317.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN76ed9122-b845-423b-a6d5-a47b3174331713
197320allopurinol 300 MG Oral TabletSCD76ed9122-b845-423b-a6d5-a47b3174331713

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0112-17133501120130 TABLET in 1 BOTTLE (71335-0112-1) 30 tablet2018-04-130000-00-00NoNoCurrent
71335-0112-27133501120260 TABLET in 1 BOTTLE (71335-0112-2) 60 tablet2018-05-160000-00-00NoNoCurrent
71335-0112-371335011203100 TABLET in 1 BOTTLE (71335-0112-3) 100 tablet2018-09-180000-00-00NoNoCurrent
71335-0112-47133501120490 TABLET in 1 BOTTLE (71335-0112-4) 90 tablet2018-04-180000-00-00NoNoCurrent
71335-0112-57133501120520 TABLET in 1 BOTTLE (71335-0112-5) 20 tablet2021-12-270000-00-00NoNoCurrent