Allopurinol

Product NDC
70934-979
Requested package NDC
70934-979-90
11-digit product format
709340979
Labeler code
70934
Product ID
70934-979_f14e93e8-eddf-18bd-e053-2995a90a290b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA204467
Marketing category
ANDA
Marketing start
2022-06-09
Marketing end
2024-10-31
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

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 packagepackage70934-97970934-979-90DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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…

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
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-979-907093409799090 TABLET in 1 BOTTLE, PLASTIC (70934-979-90) 90 tablet2022-06-092024-10-31NoNoCurrent