Allopurinol

Product NDC
0615-8385
11-digit product format
006158385
Labeler code
0615
Product ID
0615-8385_15f23e0f-50fc-4ac9-8f68-c0b453eda0c9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, LLC dba Vangard Labs
Application
ANDA075798
Marketing category
ANDA
Marketing start
2003-06-27
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
0615-8385-05Allopurinol15 in 1 BLISTER PACKTABLET1536
0615-8385-39Allopurinol30 in 1 BLISTER PACKTABLET3036

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0615-8385ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS]3Current NDC, Legacy NDC, 2 package rows20241004_1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197319allopurinol 100 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-8385-050061583850515 TABLET in 1 BLISTER PACK (0615-8385-05) 15 tablet2021-02-090000-00-00NoNoCurrent
0615-8385-390061583853930 TABLET in 1 BLISTER PACK (0615-8385-39) 30 tablet2021-02-090000-00-00NoNoCurrent