FDA.reportPublic FDA data

Allopurinol

Product NDC
55154-7981
11-digit product format
551547981
Labeler code
55154
Product ID
55154-7981_92a3e407-8f4f-4ca2-9e68-14c2ed9786b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Cardinal Health 107, 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
2027-12-31
Current FDA listing
Yes

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
ndc (product): 55154-7981
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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
b6c5b5c0-b1cb-44c0-a849-5d317e6fa300Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-7981-0Allopurinol1 in 1 BLISTER PACKTABLET18
55154-7981-0Allopurinol10 in 1 BAGTABLET108

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55154-7981ALLOPURINOL TABLET [CARDINAL HEALTH 107, LLC]7Current NDC, Legacy NDC, 2 package rows20250131_b6c5b5c0-b1cb-44c0-a849-5d317e6fa300.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSNb6c5b5c0-b1cb-44c0-a849-5d317e6fa3008
197320allopurinol 300 MG Oral TabletSCDb6c5b5c0-b1cb-44c0-a849-5d317e6fa3008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55154-7981-05515479810010 BLISTER PACK in 1 BAG (55154-7981-0) / 1 TABLET in 1 BLISTER PACK10 blister pack2003-06-270000-00-00NoNoCurrent