FDA.reportPublic FDA data

Allopurinol

Product NDC
68071-2997
11-digit product format
680712997
Labeler code
68071
Product ID
68071-2997_2d53e60e-6f9e-182d-e063-6294a90ab7f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA211820
Marketing category
ANDA
Marketing start
2019-03-12
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2026-12-31

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
68071-2997-32025-02-04C16284748780-12cef2736-b3c3-d83d-e063-dadaa90ab31fALLOPURINOL tablets USP Rx Only
68071-2997-92025-02-04C16284748780-12cef2736-b3c3-d83d-e063-dadaa90ab31fALLOPURINOL tablets USP Rx Only
68071-2997-32025-01-30C16284748780-12cef2736-b3c3-d83d-e063-dadaa90ab31fALLOPURINOL tablets USP Rx Only
68071-2997-92025-01-30C16284748780-12cef2736-b3c3-d83d-e063-dadaa90ab31fALLOPURINOL tablets USP Rx Only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2997-3Allopurinol30 in 1 BOTTLE, PLASTICTABLET303
68071-2997-9Allopurinol90 in 1 BOTTLE, PLASTICTABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2997ALLOPURINOL TABLET [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 2 package rows20250206_faf55184-6962-d49f-e053-6394a90a152e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNfaf55184-6962-d49f-e053-6394a90a152e3
197319allopurinol 100 MG Oral TabletSCDfaf55184-6962-d49f-e053-6394a90a152e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-2997-36807129970330 TABLET in 1 BOTTLE, PLASTIC (68071-2997-3) 30 tablet2023-05-05NoNoCurrent
68071-2997-96807129970990 TABLET in 1 BOTTLE, PLASTIC (68071-2997-9) 90 tablet2023-05-05NoNoCurrent