Allopurinol

Product NDC
53489-157
11-digit product format
534890157
Labeler code
53489
Product ID
53489-157_4c3692cf-dd55-f58c-e063-6394a90a1373
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071450
Marketing category
ANDA
Marketing start
1987-01-09
Substance
ALLOPURINOL
Active strength
300 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
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
53489-157-01Allopurinol100 in 1 BOTTLE, PLASTICTABLET10010
53489-157-02Allopurinol50 in 1 BOTTLE, PLASTICTABLET5010
53489-157-05Allopurinol500 in 1 BOTTLE, PLASTICTABLET50010
53489-157-07Allopurinol30 in 1 BOTTLE, PLASTICTABLET3010
53489-157-10Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-157-01EA - Each53489-157d7901add-d17c-4094-84e5-6676820bded912016-01-13
53489-157-05EA - Each53489-157bc7eec1c-290f-454c-8bac-3e459c0daa6312016-01-13
53489-157-10EA - Each53489-157eeedc9af-bfd9-4501-9355-65bf2491dad612016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllopurinolACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [MUTUAL PHARMACEUTICAL]5
AllopurinolACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [MUTUAL PHARMACEUTICAL]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-157ALLOPURINOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 5 package rows20240216_fd8f8b8b-f25e-46e9-969a-65363b66e09b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSNf1c11f74-1de2-484c-b40b-d0013e8fd01a19
197320allopurinol 300 MG Oral TabletSCDf1c11f74-1de2-484c-b40b-d0013e8fd01a19
197320allopurinol 300 MG Oral TabletPSN211e47c6-85b9-43e8-9e07-6cc4b8f708a017
197320allopurinol 300 MG Oral TabletSCD211e47c6-85b9-43e8-9e07-6cc4b8f708a017
197319allopurinol 100 MG Oral TabletPSNfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197320allopurinol 300 MG Oral TabletPSNfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197319allopurinol 100 MG Oral TabletSCDfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197320allopurinol 300 MG Oral TabletSCDfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197320allopurinol 300 MG Oral TabletPSNd30429f1-48d6-421c-8a7e-1fad97499fa55
197320allopurinol 300 MG Oral TabletPSN7e6fbb4b-06fb-4405-b170-db905836a0e35
197320allopurinol 300 MG Oral TabletSCDd30429f1-48d6-421c-8a7e-1fad97499fa55
197320allopurinol 300 MG Oral TabletSCD7e6fbb4b-06fb-4405-b170-db905836a0e35
197320allopurinol 300 MG Oral TabletPSNdf745f5f-7f05-205d-e053-2995a90a05a44
197320allopurinol 300 MG Oral TabletSCDdf745f5f-7f05-205d-e053-2995a90a05a44
197320allopurinol 300 MG Oral TabletPSNb20c6ed4-6b94-4a1b-b448-e910856fa8253
197320allopurinol 300 MG Oral TabletSCDb20c6ed4-6b94-4a1b-b448-e910856fa8253
197320allopurinol 300 MG Oral TabletPSNbb8f09b6-c9f5-4deb-81e1-8d743e6221261
197320allopurinol 300 MG Oral TabletSCDbb8f09b6-c9f5-4deb-81e1-8d743e6221261

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-157-0153489015701100 TABLET in 1 BOTTLE, PLASTIC (53489-157-01) 100 tablet1987-01-090000-00-00NoNoCurrent
53489-157-025348901570250 TABLET in 1 BOTTLE, PLASTIC (53489-157-02) 50 tablet1987-01-090000-00-00NoNoCurrent
53489-157-0553489015705500 TABLET in 1 BOTTLE, PLASTIC (53489-157-05) 500 tablet1987-01-090000-00-00NoNoCurrent
53489-157-075348901570730 TABLET in 1 BOTTLE, PLASTIC (53489-157-07) 30 tablet1987-01-090000-00-00NoNoCurrent
53489-157-10534890157101000 TABLET in 1 BOTTLE, PLASTIC (53489-157-10) 1000 tablet1987-01-090000-00-00NoNoCurrent