FDA.reportPublic FDA data

Allopurinol

Product NDC
0378-0181
11-digit product format
003780181
Labeler code
0378
Product ID
0378-0181_38f49ed2-9641-404b-8146-5555064b86e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
ANDA018659
Marketing category
ANDA
Marketing start
1986-10-24
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
0378-0181-01Allopurinol100 in 1 BOTTLETABLET10020
0378-0181-05Allopurinol500 in 1 BOTTLETABLET50020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0378-0181-01EA - Each0378-0181439c63b1-9303-4d4d-b39a-0ac5acc2c25412012-07-24
0378-0181-05EA - Each0378-01819de0bd5b-1ff4-48b4-9ad0-0c201cd3e4eb12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]11
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
0378-0181ALLOPURINOL TABLET [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy NDC, 2 package rows20240405_bdbf5ad4-86f2-4e9c-a51a-fb0c7220c480.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN5dca2d4f-0e93-4d1a-8d9f-b9b72867c242103
197320allopurinol 300 MG Oral TabletSCD5dca2d4f-0e93-4d1a-8d9f-b9b72867c242103
197319allopurinol 100 MG Oral TabletPSNbdbf5ad4-86f2-4e9c-a51a-fb0c7220c48020
197320allopurinol 300 MG Oral TabletPSNbdbf5ad4-86f2-4e9c-a51a-fb0c7220c48020
197319allopurinol 100 MG Oral TabletSCDbdbf5ad4-86f2-4e9c-a51a-fb0c7220c48020
197320allopurinol 300 MG Oral TabletSCDbdbf5ad4-86f2-4e9c-a51a-fb0c7220c48020
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
197320allopurinol 300 MG Oral TabletPSN7c7eafa6-5411-470c-8a45-cfbc85d3e3354
197320allopurinol 300 MG Oral TabletSCD7c7eafa6-5411-470c-8a45-cfbc85d3e3354
197320allopurinol 300 MG Oral TabletPSNaea483a7-4ce7-4fe5-936c-fd876b4fa3a83
197320allopurinol 300 MG Oral TabletSCDaea483a7-4ce7-4fe5-936c-fd876b4fa3a83
197319allopurinol 100 MG Oral TabletPSNdbfb3bde-2274-43cc-b726-d4578ebdb5d42
197320allopurinol 300 MG Oral TabletPSNdbfb3bde-2274-43cc-b726-d4578ebdb5d42
197320allopurinol 300 MG Oral TabletPSN65171cf0-8486-1ca6-e053-2991aa0ab91f2
197319allopurinol 100 MG Oral TabletSCDdbfb3bde-2274-43cc-b726-d4578ebdb5d42
197320allopurinol 300 MG Oral TabletSCD65171cf0-8486-1ca6-e053-2991aa0ab91f2
197320allopurinol 300 MG Oral TabletSCDdbfb3bde-2274-43cc-b726-d4578ebdb5d42
197320allopurinol 300 MG Oral TabletPSN15d758f9-2ec5-ecf5-e063-6394a90a7a2c1
197320allopurinol 300 MG Oral TabletSCD15d758f9-2ec5-ecf5-e063-6394a90a7a2c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0378-0181-0100378018101100 TABLET in 1 BOTTLE (0378-0181-01) 100 tablet1986-10-240000-00-00NoNoCurrent
0378-0181-0500378018105500 TABLET in 1 BOTTLE (0378-0181-05) 500 tablet1986-10-240000-00-00NoNoCurrent