FDA.reportPublic FDA data

Allopurinol

Product NDC
0603-2116
11-digit product format
006032116
Labeler code
0603
Product ID
0603-2116_bb93f828-90b4-4844-9256-f4f964243818
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA075798
Marketing category
ANDA
Marketing start
2003-06-27
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL300 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0603-2116-022022-09-16C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-212022-09-16C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-282022-09-16C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-322022-09-16C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-022022-07-29C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-212022-07-29C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-282022-07-29C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2116-322022-07-29C16284748780-1e4f33bdf-9ea2-d8a0-e053-dadaa90a6e4eThese highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-2116-02Allopurinol90 in 1 BOTTLE, PLASTICTABLET9034
0603-2116-21Allopurinol100 in 1 BOTTLE, PLASTICTABLET10034
0603-2116-28Allopurinol500 in 1 BOTTLE, PLASTICTABLET50034
0603-2116-32Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2116-02EA - Each0603-21164ac37f04-35af-4d59-ab96-b75bfde467ef12012-07-24
0603-2116-21EA - Each0603-2116d9dbe784-f071-4cc7-ba4f-84d44c05539f12012-07-24
0603-2116-28EA - Each0603-2116c9e5cfc4-f1c6-49fa-9e41-220f16d1438612012-07-24
0603-2116-32EA - Each0603-21169cd62101-448f-432c-a25d-723a789308a112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-2116ALLOPURINOL TABLET [ENDO USA, INC.]33Current NDC, Legacy NDC, 4 package rows20241212_fbac3b4f-dc23-4359-ac3f-2b3fdde41af2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN005048dd-844f-468c-bf56-1a09727e3477103
197320allopurinol 300 MG Oral TabletPSN73a374a6-ea1a-40a1-b6eb-d42654df0895103
197320allopurinol 300 MG Oral TabletSCD005048dd-844f-468c-bf56-1a09727e3477103
197320allopurinol 300 MG Oral TabletSCD73a374a6-ea1a-40a1-b6eb-d42654df0895103
197320allopurinol 300 MG Oral TabletPSNe84cd8df-79d8-449f-ace2-5a4de1cdaf51102
197320allopurinol 300 MG Oral TabletSCDe84cd8df-79d8-449f-ace2-5a4de1cdaf51102
197319allopurinol 100 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197319allopurinol 100 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197319allopurinol 100 MG Oral TabletPSNfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197320allopurinol 300 MG Oral TabletPSNfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197319allopurinol 100 MG Oral TabletSCDfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197320allopurinol 300 MG Oral TabletSCDfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197320allopurinol 300 MG Oral TabletPSN8c0f5af5-a453-4641-933f-ccb2625fca3911
197320allopurinol 300 MG Oral TabletSCD8c0f5af5-a453-4641-933f-ccb2625fca3911
197319allopurinol 100 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletPSN4dbced9a-ef6f-455e-8d5d-b635409521db2
197319allopurinol 100 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletSCD4dbced9a-ef6f-455e-8d5d-b635409521db2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2116-020060321160290 in 1 BOTTLE, PLASTICHistorical
0603-2116-2100603211621100 TABLET in 1 BOTTLE, PLASTIC (0603-2116-21) 100 tablet2003-06-270000-00-00NoNoCurrent
0603-2116-2800603211628500 TABLET in 1 BOTTLE, PLASTIC (0603-2116-28) 500 tablet2003-06-270000-00-00NoNoCurrent
0603-2116-32006032116321000 TABLET in 1 BOTTLE, PLASTIC (0603-2116-32) 1000 tablet2003-06-270000-00-00NoNoCurrent