FDA.reportPublic FDA data

Allopurinol

Product NDC
51655-546
11-digit product format
516550546
Labeler code
51655
Product ID
51655-546_4a2a4f63-133c-8b7a-e063-6294a90a0a5e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071586
Marketing category
ANDA
Marketing start
2023-06-08
Substance
ALLOPURINOL
Active strength
100 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
ALLOPURINOL100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319

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
51655-546-262026-01-29C16284748780-149896155-a6ee-586f-e063-e6dba90add90These highlights do not include all the information needed to use Allopurinol Tablets safely and effectively. See full prescribing information for Allopurinol Tablets. Allopurinol Tablets® (allopurinol) tablets, for oral use Initial U.S. Approval:1966
51655-546-522026-01-29C16284748780-149896155-a6ee-586f-e063-e6dba90add90These highlights do not include all the information needed to use Allopurinol Tablets safely and effectively. See full prescribing information for Allopurinol Tablets. Allopurinol Tablets® (allopurinol) tablets, for oral use Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51655-546-26Allopurinol90 in 1 BOTTLE, PLASTICTABLET903
51655-546-52Allopurinol30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-546ALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS, LLC]1Current NDC, 2 package rows20240127_fe06da1b-c493-e238-e053-6294a90a9195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNfe06da1b-c493-e238-e053-6294a90a91953
197319allopurinol 100 MG Oral TabletSCDfe06da1b-c493-e238-e053-6294a90a91953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-546-265165505462690 TABLET in 1 BOTTLE, PLASTIC (51655-546-26) 90 tablet2023-10-04NoNoHistorical
51655-546-525165505465230 TABLET in 1 BOTTLE, PLASTIC (51655-546-52) 30 tablet2023-06-08NoNoHistorical