FDA.reportPublic FDA data

Allopurinol

Product NDC
21695-246
11-digit product format
216950246
Labeler code
21695
Product ID
21695-246_66e300a5-f1de-40e0-9b08-8b86e2394016
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA018832
Marketing category
ANDA
Marketing start
2009-06-01
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
E
Listing certified through
2017-12-31
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
21695-246-302019-09-24C16284748780-1934fe258-498c-48b1-e053-8cdaa90a720aAllopurinol Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-246-30Allopurinol30 in 1 BOTTLETABLET301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-246-30EA - Each21695-246f9a4c87d-5d10-4be5-a1b4-1abb0828dc7312012-07-24

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-246ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 1 package rows20100329_c87fceaa-0e56-4042-95a2-08e7c0d6bc47.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197320allopurinol 300 MG Oral TabletPSNc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197319allopurinol 100 MG Oral TabletSCDc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197320allopurinol 300 MG Oral TabletSCDc87fceaa-0e56-4042-95a2-08e7c0d6bc471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-246-302169502463030 in 1 BOTTLEHistorical