FDA.reportPublic FDA data

ALLOPURINOL

Product NDC
31722-252
11-digit product format
317220252
Labeler code
31722
Product ID
31722-252_2a7490a6-7492-4fe1-b0f5-0e22bd0d458a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ALLOPURINOL
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals, Inc.
Application
ANDA217748
Marketing category
ANDA
Marketing start
2023-08-03
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, 197320

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
31722-252-01ALLOPURINOL100 in 1 BOTTLETABLET1004
31722-252-05ALLOPURINOL500 in 1 BOTTLETABLET5004
31722-252-10ALLOPURINOL1000 in 1 BOTTLETABLET10004
31722-252-90ALLOPURINOL90 in 1 BOTTLETABLET904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-252-01EA - Each31722-2528588aa72-1b07-4909-b28d-637133cabab412024-04-05
31722-252-05EA - Each31722-25274f31df2-afe2-47e5-8393-4bac642aa4ab12024-04-05
31722-252-10EA - Each31722-2524367f9c2-5163-479c-ad5a-55d96304524c12024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
31722-252ALLOPURINOL TABLET [CAMBER PHARMACEUTICALS, INC.]4Current NDC, 4 package rows20241121_60750373-7146-455a-8d12-d0e32d2d4bc8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN60750373-7146-455a-8d12-d0e32d2d4bc84
197320allopurinol 300 MG Oral TabletPSN60750373-7146-455a-8d12-d0e32d2d4bc84
197319allopurinol 100 MG Oral TabletSCD60750373-7146-455a-8d12-d0e32d2d4bc84
197320allopurinol 300 MG Oral TabletSCD60750373-7146-455a-8d12-d0e32d2d4bc84
197319allopurinol 100 MG Oral TabletPSN5955ca3f-9383-4025-ac58-90394716493a1
197319allopurinol 100 MG Oral TabletPSN78978de2-1842-4570-9d11-67f13cc37ad51
197319allopurinol 100 MG Oral TabletPSN8047206e-305b-44d2-aa61-dff0366e76751
197319allopurinol 100 MG Oral TabletPSNd83fec65-396a-40bd-8ee8-828d8930ea411
197319allopurinol 100 MG Oral TabletPSNe453a5e0-44c3-4eb5-a8d0-7c02157d2f8c1
197319allopurinol 100 MG Oral TabletSCD5955ca3f-9383-4025-ac58-90394716493a1
197319allopurinol 100 MG Oral TabletSCD78978de2-1842-4570-9d11-67f13cc37ad51
197319allopurinol 100 MG Oral TabletSCD8047206e-305b-44d2-aa61-dff0366e76751
197319allopurinol 100 MG Oral TabletSCDd83fec65-396a-40bd-8ee8-828d8930ea411
197319allopurinol 100 MG Oral TabletSCDe453a5e0-44c3-4eb5-a8d0-7c02157d2f8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
31722-252-0131722025201100 TABLET in 1 BOTTLE (31722-252-01) 100 tablet2023-08-03NoNoHistorical
31722-252-0531722025205500 TABLET in 1 BOTTLE (31722-252-05) 500 tablet2023-08-03NoNoHistorical
31722-252-10317220252101000 TABLET in 1 BOTTLE (31722-252-10) 1000 tablet2023-08-03NoNoHistorical
31722-252-903172202529090 TABLET in 1 BOTTLE (31722-252-90) 90 tablet2023-08-03NoNoHistorical