Allopurinol

Product NDC
71921-240
11-digit product format
719210240
Labeler code
71921
Product ID
71921-240_88cf17e7-9773-490a-992b-63525120cadc
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Florida Pharmaceutical Products, LLC
Application
ANDA204467
Marketing category
ANDA
Marketing start
2023-10-31
Substance
ALLOPURINOL
Active strength
100 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 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204467-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2016-07-28
A204467-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2016-07-28
A204467-003ALLOPURINOLALLOPURINOL200MGTABLET / ORALAB2025-05-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A204467-001AB
A204467-002AB
A204467-003AB

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.

Product history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204467-003ALLOPURINOL200MGTABLET / ORALAB2025-05-22011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-2831067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-003ALLOPURINOL200MGTABLET / ORALAB2025-05-2231067a03dcf5…
2025-08-23 18:47 UTC2025-08A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-286a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204467-003ALLOPURINOL200MGTABLET / ORALAB2025-05-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-2803ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-282680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-285bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28d06236e962d9…
2024-10-29 15:01 UTC2024-10A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-2879d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-281e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-288072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-285c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-285d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-284b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-2874a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204467-002ALLOPURINOL300MGTABLET / ORALAB2016-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204467-001ALLOPURINOL100MGTABLET / ORALAB2016-07-28bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 86 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A204467-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204467-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A204467-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204467-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A204467-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204467-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A204467-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204467-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204467-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204467-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204467-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204467-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204467-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204467-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204467-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204467-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204467-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204467-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204467-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204467-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A204467-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204467-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204467-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204467-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204467-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204467-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204467-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A204467-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A204467-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204467-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204467-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204467-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A204467-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204467-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A204467-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204467-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A204467-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204467-001AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL100 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 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197319Internal RxNorm lookup
197320Internal RxNorm lookup
245422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
815af471-5985-4819-936d-1f5f3d871ef8Available 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
71921-240-01Allopurinol100 in 1 BOTTLETABLET1005
71921-240-33Allopurinol30 in 1 BOTTLETABLET305
71921-240-50Allopurinol500 in 1 BOTTLETABLET5005
71921-240-60Allopurinol1000 in 1 BOTTLETABLET10005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71921-240-01EA - Each71921-2406b4cfff1-5f29-4a55-ab67-1b8c9fb2273d12024-01-04
71921-240-50EA - Each71921-2401732d989-3c08-4390-b22c-075b489baac112024-10-04
71921-240-60EA - Each71921-240ac9e729b-915f-490d-ae07-38453af7bbeb12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71921-240ALLOPURINOL TABLET [FLORIDA PHARMACEUTICAL PRODUCTS, LLC]2Current NDC, 4 package rows20231107_815af471-5985-4819-936d-1f5f3d871ef8.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 2 · 27 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLREMEDYREPACK INC.55280a8a-cf23-405b-b698-95a4d8e3c6992026-07-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLBryant Ranch Prepack6341a72d-9c83-448c-871b-e800ad8f15472026-07-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLBryant Ranch Prepackb943dbb1-7f54-434c-9439-8ce768d94ff42026-06-10Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLSt. Mary's Medical Park Pharmacy0f8b97d0-4d0b-9f4a-e063-6294a90a033f2026-06-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLBryant Ranch Prepackfc37bc7e-b6bc-4aa9-a6f3-6e11285c4f052026-05-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLBryant Ranch Prepack30529a62-f95a-40e0-b4c5-2cfc092320682026-04-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLST. MARY'S MEDICAL PARK PHARMACY4f5c4fbc-3d31-5068-e063-6294a90ab3152026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
ALLOPURINOLALLOPURINOLDirect_Rxf3bd5852-8e43-6b5d-e053-2995a90a194f2026-03-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.6d2f2f76-0f2b-45c4-affe-77bd927df5892026-02-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLCoupler LLC4a00a35a-cc85-0088-e063-6394a90a07442026-02-16Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLFlorida Pharmaceutical Products, LLC815af471-5985-4819-936d-1f5f3d871ef82026-02-05Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
ndc (product): 71921-240
AllopurinolALLOPURINOLREMEDYREPACK INC.52ce5aab-76cf-465d-8f14-c745d382cd152026-01-27Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLNorthwind Health Company, LLCdf754efc-4b73-a0ab-e053-2a95a90a61332026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.ad6950d4-2cdd-44ac-9b8a-120716460e702025-12-29Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLREMEDYREPACK INC.165f2ebb-a099-4d31-b21a-93b341c394292025-09-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLIndoco Remedies Limited48a9a6c3-4604-421e-a323-1133888aaf762025-08-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLNuCare Pharmaceuticals,Inc.3845c310-099b-8e11-e063-6394a90abd2f2025-06-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLRedpharm Drug0a22fa72-c363-4e96-e063-6394a90a48aa2025-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.7f9ad8db-ae68-4a0c-b858-1e727bc981302025-01-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467
AllopurinolALLOPURINOLA-S Medication Solutions74dba96f-d388-40fe-8bca-53086d28c9542024-12-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 204467
application number: ANDA204467

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNb943dbb1-7f54-434c-9439-8ce768d94ff4101
197319allopurinol 100 MG Oral TabletSCDb943dbb1-7f54-434c-9439-8ce768d94ff4101
197319allopurinol 100 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
245422allopurinol 200 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
197320allopurinol 300 MG Oral TabletPSN815af471-5985-4819-936d-1f5f3d871ef85
197319allopurinol 100 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
245422allopurinol 200 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
197320allopurinol 300 MG Oral TabletSCD815af471-5985-4819-936d-1f5f3d871ef85
197319allopurinol 100 MG Oral TabletPSN266dbae7-ea4b-7348-e063-6394a90af9ea1
197319allopurinol 100 MG Oral TabletSCD266dbae7-ea4b-7348-e063-6394a90af9ea1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71921-240-0171921024001100 TABLET in 1 BOTTLE (71921-240-01) 100 tablet2023-10-31NoNoCurrent
71921-240-337192102403330 TABLET in 1 BOTTLE (71921-240-33) 30 tablet2023-10-31NoNoCurrent
71921-240-5071921024050500 TABLET in 1 BOTTLE (71921-240-50) 500 tablet2023-10-31NoNoCurrent
71921-240-60719210240601000 TABLET in 1 BOTTLE (71921-240-60) 1000 tablet2023-10-31NoNoCurrent