Allopurinol

Product NDC
70934-882
Requested package NDC
70934-882-30
11-digit product format
709340882
Labeler code
70934
Product ID
70934-882_c93a5933-d9fc-3e59-e053-2a95a90ace4d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Denton Pharma, Inc. DBA Northwind Pharmaceuticals
Application
ANDA071586
Marketing category
ANDA
Marketing start
2021-08-10
Marketing end
2025-01-31
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 packagepackage70934-88270934-882-30DDiscontinued by firm2026-08-17

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 · 6 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…

Source provenance: Browse the complete Orange Book source catalog.

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 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071586-001LOPURIN100MGTABLET / ORALAB1987-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071586-001LOPURIN100MGTABLET / ORALAB1987-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071586-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071586-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071586-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071586-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071586-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071586-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071586-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071586-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071586-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071586-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071586-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071586-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071586-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071586-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071586-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071586-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071586-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071586-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071586-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071586-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071586-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071586-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071586-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071586-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071586-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071586-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071586-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071586-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071586-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071586-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071586-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071586-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071586-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071586-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071586-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071586-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071586-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071586-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071586-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071586-001AB1cb3db0bc1861…

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 1 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLNorthwind Health Company, LLCfe06da1b-c493-e238-e053-6294a90a91952026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
AllopurinolALLOPURINOLDr. Reddy's Laboratories Limited19a138b8-d225-03e6-f762-abe71560204b2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
AllopurinolALLOPURINOLBryant Ranch Prepack5a1bfae2-116f-4ef9-bb7b-3b69ac74df032025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC3dc4980c-8062-4239-a860-63888cabee462021-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70934-882-307093408823030 TABLET in 1 BOTTLE, PLASTIC (70934-882-30) 30 tablet2021-08-102025-01-31NoNoCurrent