FDA.reportPublic FDA data

Allopurinol

Product NDC
16571-885
11-digit product format
165710885
Labeler code
16571
Product ID
16571-885_5cd32f4f-2795-4776-ad00-f33f91bda391
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Rising Pharma Holdings, Inc.
Application
NDA016084
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-09-21
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
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL300 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319, 197320, 245422

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
16571-885-01Allopurinol100 in 1 BOTTLETABLET1004
16571-885-09Allopurinol90 in 1 BOTTLETABLET904
16571-885-10Allopurinol1000 in 1 BOTTLETABLET10004
16571-885-50Allopurinol500 in 1 BOTTLETABLET5004

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16571-885-09EA - Each16571-885e6a49fde-de1f-407a-98aa-c8b8f23a747a12024-02-14
16571-885-50EA - Each16571-885a77bb8e5-ddc5-40b9-8038-f1f91231b8d712024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16571-885ALLOPURINOL TABLET [RISING PHARMA HOLDINGS, INC.]4Current NDC, Legacy NDC, 4 package rows20231219_30ad5ba2-1cef-4933-b104-0597f6a2aaa2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN30ad5ba2-1cef-4933-b104-0597f6a2aaa24
245422allopurinol 200 MG Oral TabletPSN30ad5ba2-1cef-4933-b104-0597f6a2aaa24
197320allopurinol 300 MG Oral TabletPSN30ad5ba2-1cef-4933-b104-0597f6a2aaa24
197319allopurinol 100 MG Oral TabletSCD30ad5ba2-1cef-4933-b104-0597f6a2aaa24
245422allopurinol 200 MG Oral TabletSCD30ad5ba2-1cef-4933-b104-0597f6a2aaa24
197320allopurinol 300 MG Oral TabletSCD30ad5ba2-1cef-4933-b104-0597f6a2aaa24
197320allopurinol 300 MG Oral TabletPSN2d6ce57f-a9df-319e-e063-6394a90ac93f1
197320allopurinol 300 MG Oral TabletSCD2d6ce57f-a9df-319e-e063-6394a90ac93f1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16571-885-0116571088501100 TABLET in 1 BOTTLE (16571-885-01) 100 tablet2023-09-21NoNoHistorical
16571-885-091657108850990 TABLET in 1 BOTTLE (16571-885-09) 90 tablet2023-09-210000-00-00NoNoCurrent
16571-885-10165710885101000 TABLET in 1 BOTTLE (16571-885-10) 1000 tablet2023-09-21NoNoHistorical
16571-885-5016571088550500 TABLET in 1 BOTTLE (16571-885-50) 500 tablet2023-09-21NoNoHistorical