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

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-21160603-2116-02DDiscontinued by firm2026-07-31

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075798-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2003-06-27
A075798-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2003-06-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A075798-001AB
A075798-002AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27a50c72e98297…
2026-08-01 22:54:322026-06A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A075798-001AB1a50c72e98297…
2026-08-01 22:54:322026-06A075798-002AB1a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLCardinal Health 107, LLCb6c5b5c0-b1cb-44c0-a849-5d317e6fa3002026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLMajor Pharmaceuticals8c0f5af5-a453-4641-933f-ccb2625fca392026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLNCS HealthCare of KY, LLC dba Vangard Labs1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLREMEDYREPACK INC.4dbced9a-ef6f-455e-8d5d-b635409521db2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack73a374a6-ea1a-40a1-b6eb-d42654df08952024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepackf91c2183-e41d-45bc-87aa-edfca5eebac52024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack005048dd-844f-468c-bf56-1a09727e34772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack90912dd4-5abf-4fd3-8fc1-3afd057b743f2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepacke84cd8df-79d8-449f-ace2-5a4de1cdaf512024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLPar Health USA, LLCfbac3b4f-dc23-4359-ac3f-2b3fdde41af22024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 0603-2116

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
63CZ7GJN5IInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197319Internal RxNorm lookup
197320Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
fbac3b4f-dc23-4359-ac3f-2b3fdde41af2Available on FDA.report

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
0603-2116-022022-09-16C16284748780-1e4f33bdf-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
0603-2116-212022-09-16C16284748780-1e4f33bdf-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
0603-2116-282022-09-16C16284748780-1e4f33bdf-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
0603-2116-322022-09-16C16284748780-1e4f33bdf-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
0603-2116-022022-07-29C16284748780-1e4f33bdf-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
0603-2116-212022-07-29C16284748780-1e4f33bdf-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
0603-2116-282022-07-29C16284748780-1e4f33bdf-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
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 [PD-RX PHARMACEUTICALS, INC.]5
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [PD-RX PHARMACEUTICALS, INC.]5
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