FDA.reportPublic FDA data

Allopurinol

Product NDC
53489-156
11-digit product format
534890156
Labeler code
53489
Product ID
53489-156_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
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, 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
53489-156-01Allopurinol100 in 1 BOTTLE, PLASTICTABLET10010
53489-156-02Allopurinol50 in 1 BOTTLE, PLASTICTABLET5010
53489-156-05Allopurinol500 in 1 BOTTLE, PLASTICTABLET50010
53489-156-10Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-156-01EA - Each53489-156e02e34c4-27a0-41fe-b90f-b15f6ebe467e12016-01-13
53489-156-05EA - Each53489-1566ac4661b-0fff-482a-b861-86e2054102bc12016-01-13
53489-156-10EA - Each53489-156fe1759f7-475e-4b84-b0b3-41b0ac8f774b12016-01-13

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
53489-156ALLOPURINOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 4 package rows20240216_fd8f8b8b-f25e-46e9-969a-65363b66e09b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNf130c9c0-45d8-42bc-a040-04bb077671f818
197319allopurinol 100 MG Oral TabletSCDf130c9c0-45d8-42bc-a040-04bb077671f818
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
197319allopurinol 100 MG Oral TabletPSNf67d4aa7-6e5f-bba1-e053-2a95a90a11943
197319allopurinol 100 MG Oral TabletPSNbfd3bd12-ebe7-486c-8338-824b05fff1b13
197319allopurinol 100 MG Oral TabletPSN06cf0f4b-aef0-472e-b5c0-56e0c35354f23
197319allopurinol 100 MG Oral TabletSCDbfd3bd12-ebe7-486c-8338-824b05fff1b13
197319allopurinol 100 MG Oral TabletSCDf67d4aa7-6e5f-bba1-e053-2a95a90a11943
197319allopurinol 100 MG Oral TabletSCD06cf0f4b-aef0-472e-b5c0-56e0c35354f23
197319allopurinol 100 MG Oral TabletPSN3f5905f1-243e-4880-ad1c-d34064f173562
197319allopurinol 100 MG Oral TabletSCD3f5905f1-243e-4880-ad1c-d34064f173562
197319allopurinol 100 MG Oral TabletPSN57fa94ed-b29e-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletPSN156d743c-6324-44db-9230-21f762d64cfd1
197319allopurinol 100 MG Oral TabletSCD57fa94ed-b29e-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletSCD156d743c-6324-44db-9230-21f762d64cfd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-156-0153489015601100 TABLET in 1 BOTTLE, PLASTIC (53489-156-01) 100 tablet1987-01-090000-00-00NoNoCurrent
53489-156-025348901560250 TABLET in 1 BOTTLE, PLASTIC (53489-156-02) 50 tablet1987-01-090000-00-00NoNoCurrent
53489-156-0553489015605500 TABLET in 1 BOTTLE, PLASTIC (53489-156-05) 500 tablet1987-01-090000-00-00NoNoCurrent
53489-156-10534890156101000 TABLET in 1 BOTTLE, PLASTIC (53489-156-10) 1000 tablet1987-01-090000-00-00NoNoCurrent