FDA.reportPublic FDA data

Allopurinol

Product NDC
55111-729
11-digit product format
551110729
Labeler code
55111
Product ID
55111-729_c3be239e-a0b5-fb8d-2ae6-372cef6fa362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA071586
Marketing category
ANDA
Marketing start
2009-10-01
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

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
55111-729-01Allopurinol100 in 1 BOTTLETABLET10014
55111-729-10Allopurinol1000 in 1 BOTTLETABLET100014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-729-01EA - Each55111-729f7fe4077-dc7c-4afe-a246-b7838257726212012-07-24
55111-729-10EA - Each55111-729db7de695-b720-4eae-bfdb-19e50d06c1f612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllopurinolACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
AllopurinolACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
LactoseINACTIVE INGREDIENTJ2B2A4N98GALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
Magnesium stearateINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
povidoneINACTIVE INGREDIENTFZ989GH94EALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-729ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]12Current NDC, Legacy NDC, 2 package rows20241222_19a138b8-d225-03e6-f762-abe71560204b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN19a138b8-d225-03e6-f762-abe71560204b14
197320allopurinol 300 MG Oral TabletPSN19a138b8-d225-03e6-f762-abe71560204b14
197319allopurinol 100 MG Oral TabletSCD19a138b8-d225-03e6-f762-abe71560204b14
197320allopurinol 300 MG Oral TabletSCD19a138b8-d225-03e6-f762-abe71560204b14
197319allopurinol 100 MG Oral TabletPSN3dc4980c-8062-4239-a860-63888cabee463
197319allopurinol 100 MG Oral TabletPSN5a1bfae2-116f-4ef9-bb7b-3b69ac74df033
197319allopurinol 100 MG Oral TabletPSNfe06da1b-c493-e238-e053-6294a90a91953
197319allopurinol 100 MG Oral TabletSCD3dc4980c-8062-4239-a860-63888cabee463
197319allopurinol 100 MG Oral TabletSCD5a1bfae2-116f-4ef9-bb7b-3b69ac74df033
197319allopurinol 100 MG Oral TabletSCDfe06da1b-c493-e238-e053-6294a90a91953

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-729-0155111072901100 TABLET in 1 BOTTLE (55111-729-01) 100 tablet2009-10-010000-00-00NoNoCurrent
55111-729-10551110729101000 TABLET in 1 BOTTLE (55111-729-10) 1000 tablet2009-10-010000-00-00NoNoCurrent