FDA.reportPublic FDA data

Allopurinol

Product NDC
14445-172
11-digit product format
144450172
Labeler code
14445
Product ID
14445-172_7394738d-e6ca-4be9-9fb8-28702362abc5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Indoco Remedies Limited
Application
ANDA204467
Marketing category
ANDA
Marketing start
2024-05-15
Substance
ALLOPURINOL
Active strength
200 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
ALLOPURINOL200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319, 197320, 245422

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
14445-172-00Allopurinol1000 in 1 BOTTLETABLET10002
14445-172-01Allopurinol100 in 1 BOTTLETABLET1002
14445-172-02Allopurinol10 in 1 BLISTER PACKTABLET102
14445-172-05Allopurinol500 in 1 BOTTLETABLET5002
14445-172-10Allopurinol10 in 1 CARTONTABLET102
14445-172-90Allopurinol90 in 1 BOTTLETABLET902

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN48a9a6c3-4604-421e-a323-1133888aaf762
245422allopurinol 200 MG Oral TabletPSN48a9a6c3-4604-421e-a323-1133888aaf762
197320allopurinol 300 MG Oral TabletPSN48a9a6c3-4604-421e-a323-1133888aaf762
197319allopurinol 100 MG Oral TabletSCD48a9a6c3-4604-421e-a323-1133888aaf762
245422allopurinol 200 MG Oral TabletSCD48a9a6c3-4604-421e-a323-1133888aaf762
197320allopurinol 300 MG Oral TabletSCD48a9a6c3-4604-421e-a323-1133888aaf762

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
14445-172-00144450172001000 TABLET in 1 BOTTLE (14445-172-00) 1000 tablet2025-05-22NoNoHistorical
14445-172-0114445017201100 TABLET in 1 BOTTLE (14445-172-01) 100 tablet2025-05-22NoNoHistorical
14445-172-021444501720210 in 1 BLISTER PACKHistorical
14445-172-0514445017205500 TABLET in 1 BOTTLE (14445-172-05) 500 tablet2025-05-22NoNoHistorical
14445-172-101444501721010 BLISTER PACK in 1 CARTON (14445-172-10) / 10 TABLET in 1 BLISTER PACK (14445-172-02) 10 blister pack2025-02-04NoNoHistorical
14445-172-901444501729090 TABLET in 1 BOTTLE (14445-172-90) 90 tablet2025-05-22NoNoHistorical