FDA.reportPublic FDA data

Allopurinol

Product NDC
23155-693
11-digit product format
231550693
Labeler code
23155
Product ID
23155-693_43518352-e2b6-4133-97fc-860d3eeea074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204467
Marketing category
ANDA
Marketing start
2020-09-22
Marketing end
2029-10-31
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol

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
23155-693-01Allopurinol100 in 1 BOTTLETABLET1008
23155-693-10Allopurinol1000 in 1 BOTTLETABLET10008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-693-01EA - Each23155-693856c07f3-2534-41f2-b373-8445f43b033912021-01-08
23155-693-10EA - Each23155-693e67c2be1-da35-4166-8866-afbc2a76e55112021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-693ALLOPURINOL TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20231212_ad6950d4-2cdd-44ac-9b8a-120716460e70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNfc37bc7e-b6bc-4aa9-a6f3-6e11285c4f05102
197319allopurinol 100 MG Oral TabletSCDfc37bc7e-b6bc-4aa9-a6f3-6e11285c4f05102
197319allopurinol 100 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197319allopurinol 100 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197319allopurinol 100 MG Oral TabletPSN165f2ebb-a099-4d31-b21a-93b341c394294
197319allopurinol 100 MG Oral TabletPSN6d2f2f76-0f2b-45c4-affe-77bd927df5894
197319allopurinol 100 MG Oral TabletPSNdf754efc-4b73-a0ab-e053-2a95a90a61334
197319allopurinol 100 MG Oral TabletSCD165f2ebb-a099-4d31-b21a-93b341c394294
197319allopurinol 100 MG Oral TabletSCD6d2f2f76-0f2b-45c4-affe-77bd927df5894
197319allopurinol 100 MG Oral TabletSCDdf754efc-4b73-a0ab-e053-2a95a90a61334
197319allopurinol 100 MG Oral TabletPSN0a22fa72-c363-4e96-e063-6394a90a48aa2
197319allopurinol 100 MG Oral TabletSCD0a22fa72-c363-4e96-e063-6394a90a48aa2
197319allopurinol 100 MG Oral TabletPSNf99f4637-4d67-4b3c-8741-b775a9d0bde11
197319allopurinol 100 MG Oral TabletSCDf99f4637-4d67-4b3c-8741-b775a9d0bde11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-693-0123155069301100 TABLET in 1 BOTTLE (23155-693-01) 100 tablet2020-09-222027-09-30NoNoCurrent
23155-693-02231550693021000 TABLET in 1 BOTTLE (23155-693-02) 1000 tablet2020-09-220000-00-00NoNoCurrent
23155-693-10231550693101000 TABLET in 1 BOTTLE (23155-693-10) 1000 tablet2020-09-222029-03-31NoNoCurrent