Allopurinol

Product NDC
23155-694
Requested package NDC
23155-694-01
11-digit product format
231550694
Labeler code
23155
Product ID
23155-694_43518352-e2b6-4133-97fc-860d3eeea074
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
Application
ANDA204467
Marketing category
ANDA
Marketing start
2020-09-22
Marketing end
2029-10-31
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage23155-69423155-694-01DDiscontinued by firm2026-08-03

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

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
ad6950d4-2cdd-44ac-9b8a-120716460e70Available 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
23155-694-01Allopurinol100 in 1 BOTTLETABLET1008
23155-694-05Allopurinol500 in 1 BOTTLETABLET5008

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
23155-694-01EA - Each23155-694955db619-93ea-4cbd-bb9c-cff43f44cbdf12021-01-08
23155-694-05EA - Each23155-69409bca254-9ac3-4c6d-8535-807cc8a9745812021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
23155-694ALLOPURINOL TABLET [HERITAGE PHARMACEUTICALS INC. D/B/A AVET PHARMACEUTICALS INC.]7Current NDC, Legacy NDC, 2 package rows20231212_ad6950d4-2cdd-44ac-9b8a-120716460e70.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
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
ndc (package): 23155-694-01
ndc (product): 23155-694
ndc11 (package): 23155069401
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
197320allopurinol 300 MG Oral TabletPSN30529a62-f95a-40e0-b4c5-2cfc09232068104
197320allopurinol 300 MG Oral TabletSCD30529a62-f95a-40e0-b4c5-2cfc09232068104
197319allopurinol 100 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletPSNad6950d4-2cdd-44ac-9b8a-120716460e708
197319allopurinol 100 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletSCDad6950d4-2cdd-44ac-9b8a-120716460e708
197320allopurinol 300 MG Oral TabletPSN7f9ad8db-ae68-4a0c-b858-1e727bc981303
197320allopurinol 300 MG Oral TabletPSNf3bd5852-8e43-6b5d-e053-2995a90a194f3
197320allopurinol 300 MG Oral TabletSCD7f9ad8db-ae68-4a0c-b858-1e727bc981303
197320allopurinol 300 MG Oral TabletSCDf3bd5852-8e43-6b5d-e053-2995a90a194f3
197320allopurinol 300 MG Oral TabletPSN0f8b97d0-4d0b-9f4a-e063-6294a90a033f2
197320allopurinol 300 MG Oral TabletSCD0f8b97d0-4d0b-9f4a-e063-6294a90a033f2
197320allopurinol 300 MG Oral TabletPSN1b1c5cde-b2ed-ebc8-e063-6394a90a66c61
197320allopurinol 300 MG Oral TabletSCD1b1c5cde-b2ed-ebc8-e063-6394a90a66c61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
23155-694-0123155069401100 TABLET in 1 BOTTLE (23155-694-01) 100 tablet2020-09-220000-00-00NoNoCurrent