FDA.reportPublic FDA data

Allopurinol

Product NDC
70710-1210
11-digit product format
707101210
Labeler code
70710
Product ID
70710-1210_95c7021b-a1a5-4a7f-aacf-275a64fe8b58
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Zydus Pharmaceuticals (USA) Inc.
Application
ANDA210117
Marketing category
ANDA
Marketing start
2018-02-08
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, 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
70710-1210-0Allopurinol1000 in 1 BOTTLETABLET10006
70710-1210-1Allopurinol100 in 1 BOTTLETABLET1006
70710-1210-5Allopurinol500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1210-1EA - Each70710-1210a3b7ca69-2759-4a79-87d5-dfc18897650712018-06-11
70710-1210-5EA - Each70710-1210734d7d62-e7b4-438b-a550-1aa4b37b7e5c12018-06-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1210ALLOPURINOL TABLET [ZYDUS PHARMACEUTICALS (USA) INC.]5Current NDC, Legacy NDC, 3 package rows20231101_8b926e62-3a9c-424a-833a-8169e55a1f15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN8b926e62-3a9c-424a-833a-8169e55a1f156
245422allopurinol 200 MG Oral TabletPSN8b926e62-3a9c-424a-833a-8169e55a1f156
197320allopurinol 300 MG Oral TabletPSN8b926e62-3a9c-424a-833a-8169e55a1f156
197319allopurinol 100 MG Oral TabletSCD8b926e62-3a9c-424a-833a-8169e55a1f156
245422allopurinol 200 MG Oral TabletSCD8b926e62-3a9c-424a-833a-8169e55a1f156
197320allopurinol 300 MG Oral TabletSCD8b926e62-3a9c-424a-833a-8169e55a1f156
197320allopurinol 300 MG Oral TabletPSN0c4431bc-e514-4e89-9495-025a24f399d02
197320allopurinol 300 MG Oral TabletSCD0c4431bc-e514-4e89-9495-025a24f399d02

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70710-1210-0707101210001000 TABLET in 1 BOTTLE (70710-1210-0) 1000 tablet2018-02-080000-00-00NoNoCurrent
70710-1210-170710121001100 TABLET in 1 BOTTLE (70710-1210-1) 100 tablet2018-02-080000-00-00NoNoCurrent
70710-1210-570710121005500 TABLET in 1 BOTTLE (70710-1210-5) 500 tablet2018-02-080000-00-00NoNoCurrent