FDA.reportPublic FDA data

ALLOPURINOL

Product NDC
68788-4027
11-digit product format
687884027
Labeler code
68788
Product ID
68788-4027_d83fec65-396a-40bd-8ee8-828d8930ea41
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA217748
Marketing category
ANDA
Marketing start
2025-09-22
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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63CZ7GJN5I
Rxcui197319

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
68788-4027-1ALLOPURINOL100 in 1 BOTTLETABLET1001
68788-4027-3ALLOPURINOL30 in 1 BOTTLETABLET301
68788-4027-6ALLOPURINOL60 in 1 BOTTLETABLET601
68788-4027-9ALLOPURINOL90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-4027-1EA - Each68788-4027a69925d1-e7b9-40b4-a862-9a5003003dec12026-01-08
68788-4027-3EA - Each68788-402709334b4e-0e4d-4013-8408-64315fecfeb812026-01-08
68788-4027-6EA - Each68788-402757625931-e70f-43ce-ad4c-22fbbdaae19812026-01-08
68788-4027-9EA - Each68788-40275fd214d1-c200-4c0d-a29c-9dbdde04a9ec12026-01-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNd83fec65-396a-40bd-8ee8-828d8930ea411
197319allopurinol 100 MG Oral TabletSCDd83fec65-396a-40bd-8ee8-828d8930ea411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-4027-168788402701100 TABLET in 1 BOTTLE (68788-4027-1) 100 tablet2025-09-22NoNoCurrent
68788-4027-36878840270330 TABLET in 1 BOTTLE (68788-4027-3) 30 tablet2025-09-22NoNoCurrent
68788-4027-66878840270660 TABLET in 1 BOTTLE (68788-4027-6) 60 tablet2025-09-22NoNoCurrent
68788-4027-96878840270990 TABLET in 1 BOTTLE (68788-4027-9) 90 tablet2025-09-22NoNoCurrent