FDA.reportPublic FDA data

Allopurinol

Product NDC
43063-976
11-digit product format
430630976
Labeler code
43063
Product ID
43063-976_415f7734-80d6-97e2-e063-6294a90aaa45
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA071450
Marketing category
ANDA
Marketing start
1987-01-09
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
Rxcui197320

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
43063-976-30Allopurinol30 in 1 BOTTLE, PLASTICTABLET3016
43063-976-90Allopurinol90 in 1 BOTTLE, PLASTICTABLET9016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-976-30EA - Each43063-976c8360510-48a8-4a19-9e30-6402218e505f12019-10-07
43063-976-90EA - Each43063-9763fb768c1-2ff6-419b-a9b1-541e6efc142612019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-976ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]15Current NDC, Legacy NDC, 2 package rows20240713_211e47c6-85b9-43e8-9e07-6cc4b8f708a0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN211e47c6-85b9-43e8-9e07-6cc4b8f708a017
197320allopurinol 300 MG Oral TabletSCD211e47c6-85b9-43e8-9e07-6cc4b8f708a017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-976-304306309763030 TABLET in 1 BOTTLE, PLASTIC (43063-976-30) 30 tablet2019-08-200000-00-00NoNoCurrent
43063-976-904306309769090 TABLET in 1 BOTTLE, PLASTIC (43063-976-90) 90 tablet2019-04-290000-00-00NoNoCurrent