FDA.reportPublic FDA data

Allopurinol

Product NDC
69315-291
11-digit product format
693150291
Labeler code
69315
Product ID
69315-291_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
100 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
ALLOPURINOL100 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
69315-291-01Allopurinol100 in 1 BOTTLETABLET10011
69315-291-05Allopurinol500 in 1 BOTTLETABLET50011
69315-291-10Allopurinol1000 in 1 BOTTLETABLET100011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69315-291-01EA - Each69315-291bec74523-b26a-4545-bacb-23f2060491f912023-07-06
69315-291-05EA - Each69315-2912ad41ea6-180e-4f8c-950c-403fbdf700e112023-07-06
69315-291-10EA - Each69315-291e7cf9ae1-9430-42e7-bc77-cb6d34d078d812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-291ALLOPURINOL 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
197319allopurinol 100 MG Oral TabletPSNb3b9dcf4-cada-4f79-befc-319c7dff15eb3
197319allopurinol 100 MG Oral TabletSCDb3b9dcf4-cada-4f79-befc-319c7dff15eb3
197319allopurinol 100 MG Oral TabletPSN2f27f578-f965-04c9-e063-6394a90a1ae21
197319allopurinol 100 MG Oral TabletPSN3f0134bf-b62f-1077-e063-6394a90a60b01
197319allopurinol 100 MG Oral TabletPSN42de3b18-a289-e49e-e063-6394a90a89d41
197319allopurinol 100 MG Oral TabletPSN92253e70-0b0c-4a0c-9bd6-ccea910008191
197319allopurinol 100 MG Oral TabletSCD2f27f578-f965-04c9-e063-6394a90a1ae21
197319allopurinol 100 MG Oral TabletSCD3f0134bf-b62f-1077-e063-6394a90a60b01
197319allopurinol 100 MG Oral TabletSCD42de3b18-a289-e49e-e063-6394a90a89d41
197319allopurinol 100 MG Oral TabletSCD92253e70-0b0c-4a0c-9bd6-ccea910008191

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69315-291-0169315029101100 TABLET in 1 BOTTLE (69315-291-01) 100 tablet2024-05-01NoNoHistorical
69315-291-0569315029105500 TABLET in 1 BOTTLE (69315-291-05) 500 tablet2024-05-01NoNoHistorical
69315-291-10693150291101000 TABLET in 1 BOTTLE (69315-291-10) 1000 tablet2024-05-01NoNoHistorical