FDA.reportPublic FDA data

Allopurinol

Product NDC
51079-206
11-digit product format
510790206
Labeler code
51079
Product ID
51079-206_3a3943bc-5dca-3650-e063-6394a90afa1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA018659
Marketing category
ANDA
Marketing start
1997-04-29
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
51079-206-01Allopurinol1 in 1 BLISTER PACKTABLET111
51079-206-20Allopurinol100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-206-01EA - Each51079-206dd5c5ae4-9610-46e1-9bba-482a247f02db12012-07-24
51079-206-17EA - Each51079-2061ffc82cd-7ea2-4ed8-8d29-f9f4053b05b312012-07-24
51079-206-19EA - Each51079-20622e20541-b1a7-4d6c-a0c1-f7e833d9e23b12012-07-24
51079-206-20EA - Each51079-206786202d7-3ecd-4333-bfde-3411329fd36512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [CARDINAL HEALTH]8
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [CARDINAL HEALTH]8
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-206ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20240920_994b3117-b83e-44d9-910c-1c3a26ef838e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN1ce96b87-323d-40b6-a40b-32821e00d94c22
197320allopurinol 300 MG Oral TabletPSN1ce96b87-323d-40b6-a40b-32821e00d94c22
197319allopurinol 100 MG Oral TabletSCD1ce96b87-323d-40b6-a40b-32821e00d94c22
197320allopurinol 300 MG Oral TabletSCD1ce96b87-323d-40b6-a40b-32821e00d94c22
197319allopurinol 100 MG Oral TabletPSN994b3117-b83e-44d9-910c-1c3a26ef838e11
197320allopurinol 300 MG Oral TabletPSN994b3117-b83e-44d9-910c-1c3a26ef838e11
197319allopurinol 100 MG Oral TabletSCD994b3117-b83e-44d9-910c-1c3a26ef838e11
197320allopurinol 300 MG Oral TabletSCD994b3117-b83e-44d9-910c-1c3a26ef838e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-206-01510790206011 in 1 BLISTER PACKHistorical
51079-206-2051079020620100 BLISTER PACK in 1 CARTON (51079-206-20) / 1 TABLET in 1 BLISTER PACK (51079-206-01) 100 blister pack1997-04-290000-00-00NoNoCurrent