FDA.reportPublic FDA data

Allopurinol

Product NDC
70518-0476
11-digit product format
705180476
Labeler code
70518
Product ID
70518-0476_5e87d151-6a99-8a52-e053-2a91aa0a4a8c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA075798
Marketing category
ANDA
Marketing start
2017-05-12
Marketing end
0000-00-00
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2018-12-31
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
70518-0476-02020-04-06C16284748780-19d75b9d0-9b2c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
70518-0476-02020-04-06C16284748780-19d75b9d0-9b2c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
70518-0476-02020-01-31C16284748780-19d75b9d0-9b2c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
70518-0476-02020-01-31C16284748780-19d75b9d0-9b2c-f424-e053-dadaa90a57ceThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0476ALLOPURINOL TABLET [REMEDYREPACK INC.]5Legacy NDC20250427_9138122e-844c-4613-b70e-e60d5ffcbd13.zip