FDA.reportPublic FDA data

Allopurinol

Product NDC
55289-010
11-digit product format
552890010
Labeler code
55289
Product ID
55289-010_e6e96b36-cf29-2605-e053-2a95a90abc90
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, 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
No
Listing certified through
2023-12-31
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 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct55289-010DDiscontinued by firm2026-07-31
excluded packagepackage55289-01055289-010-01DDiscontinued by firm2026-07-31
excluded packagepackage55289-01055289-010-03DDiscontinued by firm2026-07-31
excluded packagepackage55289-01055289-010-30DDiscontinued by firm2026-07-31
excluded packagepackage55289-01055289-010-90DDiscontinued 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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-010-01EA - Each55289-0105b9d353b-9ae8-4063-94e2-36d55492293f12012-07-24
55289-010-03EA - Each55289-010453879ef-0d19-4ab8-ab8b-df29bb625e5d12012-07-24
55289-010-30EA - Each55289-010d244cf11-5c8f-4f49-8305-f4d6a593e35f12012-07-24
55289-010-90EA - Each55289-01038558bfb-9f16-4239-a8f5-46b4441930ca12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-010-0155289001001100 TABLET in 1 BOTTLE, PLASTIC (55289-010-01) 100 tablet2011-08-030000-00-00NoNoCurrent
55289-010-03552890010033 TABLET in 1 BOTTLE, PLASTIC (55289-010-03) 3 tablet2011-08-030000-00-00NoNoCurrent
55289-010-305528900103030 TABLET in 1 BOTTLE, PLASTIC (55289-010-30) 30 tablet2011-08-030000-00-00NoNoCurrent
55289-010-905528900109090 TABLET in 1 BOTTLE, PLASTIC (55289-010-90) 90 tablet2011-08-030000-00-00NoNoCurrent