FDA.reportPublic FDA data

Allopurinol

Product NDC
82638-113
11-digit product format
826380113
Labeler code
82638
Product ID
82638-113_2b4201b6-c125-05d2-e063-6294a90a58c1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Harman Finochem Limited
Application
ANDA214443
Marketing category
ANDA
Marketing start
2023-10-06
Substance
ALLOPURINOL
Active strength
300 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
ALLOPURINOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319, 197320

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82638-113-02Allopurinol100 in 1 BOTTLETABLET1002
82638-113-03Allopurinol500 in 1 BOTTLETABLET5002
82638-113-04Allopurinol1000 in 1 BOTTLETABLET10002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82638-113ALLOPURINOL TABLET [HARMAN FINOCHEM LIMITED]2Current NDC, 3 package rows20250110_0780dc78-d287-d5db-e063-6294a90aa1dd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN0780dc78-d287-d5db-e063-6294a90aa1dd2
197320allopurinol 300 MG Oral TabletPSN0780dc78-d287-d5db-e063-6294a90aa1dd2
197319allopurinol 100 MG Oral TabletSCD0780dc78-d287-d5db-e063-6294a90aa1dd2
197320allopurinol 300 MG Oral TabletSCD0780dc78-d287-d5db-e063-6294a90aa1dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82638-113-0282638011302100 TABLET in 1 BOTTLE (82638-113-02) 100 tablet2023-10-06NoNoHistorical
82638-113-0382638011303500 TABLET in 1 BOTTLE (82638-113-03) 500 tablet2023-10-06NoNoHistorical
82638-113-04826380113041000 TABLET in 1 BOTTLE (82638-113-04) 1000 tablet2023-10-06NoNoHistorical