FDA.reportPublic FDA data

Allopurinol

Product NDC
67544-371
11-digit product format
675440371
Labeler code
67544
Product ID
67544-371_64ebbee6-7e2a-455f-9f96-92bc25d3e691
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, Inc.
Application
ANDA075798
Marketing category
ANDA
Marketing start
2003-06-27
Marketing end
0000-00-00
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC],Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct67544-371IInactivated by FDA2026-07-31
excluded packagepackage67544-37167544-371-30IInactivated by FDA2026-07-31
excluded packagepackage67544-37167544-371-60IInactivated by FDA2026-07-31

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

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
67544-371-302019-11-13C16284748780-197449f38-beca-f6ea-e053-dbdaa90aa703ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets
67544-371-602019-11-13C16284748780-197449f38-beca-f6ea-e053-dbdaa90aa703ALLOPURINOL 100 mg Scored Tablets and 300 mg Scored Tablets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-371-30Allopurinol30 in 1 BOTTLE, PLASTICTABLET302
67544-371-60Allopurinol90 in 1 BOTTLE, PLASTICTABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-371-30EA - Each67544-3711f8c9435-dffe-45aa-a119-2ec350b2e95612012-07-24
67544-371-60EA - Each67544-371c9be6c4c-34fb-4daf-816a-0b698c188c1412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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
67544-371ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2Legacy NDC, 2 package rows20120327_548f6fbb-155f-45ff-ab44-0a70adad4424.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197319allopurinol 100 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-371-306754403713030 in 1 BOTTLE, PLASTICHistorical
67544-371-606754403716090 in 1 BOTTLE, PLASTICHistorical