FDA.reportPublic FDA data

Allopurinol

Product NDC
33261-597
11-digit product format
332610597
Labeler code
33261
Product ID
33261-597_294053a9-959b-49d5-a4e7-f0e4e2061e4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
NDA018877
Marketing category
NDA
Marketing start
2009-04-06
Marketing end
0000-00-00
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-597-302020-01-31C16284748780-19d75b9d0-2b9f-f424-e053-dadaa90a57ceAllopurinol Tablets USP Revised: March 2009 Rx only 184001
33261-597-602020-01-31C16284748780-19d75b9d0-2b9f-f424-e053-dadaa90a57ceAllopurinol Tablets USP Revised: March 2009 Rx only 184001
33261-597-902020-01-31C16284748780-19d75b9d0-2b9f-f424-e053-dadaa90a57ceAllopurinol Tablets USP Revised: March 2009 Rx only 184001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-597-30Allopurinol30 in 1 BOTTLE, PLASTICTABLET301
33261-597-60Allopurinol60 in 1 BOTTLE, PLASTICTABLET601
33261-597-90Allopurinol90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-597-30EA - Each33261-5973be4aa81-c1d4-4e54-9539-a207f162841f12015-10-02
33261-597-60EA - Each33261-597e94ff29c-9f34-433e-8334-c1aea4acb8af12015-10-02
33261-597-90EA - Each33261-5973526b65c-74f6-441f-ba43-e30528ed8c0612015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-597ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20131204_a0c9fff0-f0ba-4bfe-ac88-afbfe31fcf68.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197320allopurinol 300 MG Oral TabletPSNa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197319allopurinol 100 MG Oral TabletSCDa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197320allopurinol 300 MG Oral TabletSCDa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-597-303326105973030 in 1 BOTTLE, PLASTICHistorical
33261-597-603326105976060 in 1 BOTTLE, PLASTICHistorical
33261-597-903326105979090 in 1 BOTTLE, PLASTICHistorical