FDA.reportPublic FDA data

Allopurinol

Product NDC
69315-292
11-digit product format
693150292
Labeler code
69315
Product ID
69315-292_227ef709-80a3-45e9-807a-2db8abee3a50
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA214443
Marketing category
ANDA
Marketing start
2024-05-01
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

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
69315-292-01Allopurinol100 in 1 BOTTLETABLET10011
69315-292-05Allopurinol500 in 1 BOTTLETABLET50011
69315-292-10Allopurinol1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-292-01EA - Each69315-2925481548a-431f-4d44-8dfa-274fb3f2c96e12023-07-06
69315-292-05EA - Each69315-292fe6ee816-926e-45a6-ba94-9f7339d87f3012023-07-06
69315-292-10EA - Each69315-2920d047b80-00f9-4f95-a3fb-a56693b5cbdb12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-292ALLOPURINOL TABLET [LEADING PHARMA, LLC]11Current NDC, 3 package rows20240926_f2e8b7fc-936c-585d-e053-2a95a90a1d6c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
245422allopurinol 200 MG Oral TabletPSNf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
197320allopurinol 300 MG Oral TabletPSNf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
197319allopurinol 100 MG Oral TabletSCDf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
245422allopurinol 200 MG Oral TabletSCDf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
197320allopurinol 300 MG Oral TabletSCDf2e8b7fc-936c-585d-e053-2a95a90a1d6c11
197320allopurinol 300 MG Oral TabletPSN92d9a9d1-76c0-4435-984d-48f44b4528553
197320allopurinol 300 MG Oral TabletSCD92d9a9d1-76c0-4435-984d-48f44b4528553
197320allopurinol 300 MG Oral TabletPSN47b8c920-4648-604e-e063-6294a90a1f542
197320allopurinol 300 MG Oral TabletSCD47b8c920-4648-604e-e063-6294a90a1f542
197320allopurinol 300 MG Oral TabletPSN20eef55e-0d70-874b-e063-6394a90aa06a1
197320allopurinol 300 MG Oral TabletSCD20eef55e-0d70-874b-e063-6394a90aa06a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-292-0169315029201100 TABLET in 1 BOTTLE (69315-292-01) 100 tablet2024-05-01NoNoHistorical
69315-292-0569315029205500 TABLET in 1 BOTTLE (69315-292-05) 500 tablet2024-05-01NoNoHistorical
69315-292-10693150292101000 TABLET in 1 BOTTLE (69315-292-10) 1000 tablet2024-05-01NoNoHistorical