Allopurinol

Product NDC
0615-1592
11-digit product format
006151592
Labeler code
0615
Product ID
0615-1592_1d646bc4-27cc-4757-87de-75de028c10d4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA018659
Marketing category
ANDA
Marketing start
1986-10-24
Marketing end
2021-07-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-1592DDiscontinued by firm2026-08-17
excluded packagepackage0615-15920615-1592-05DDiscontinued by firm2026-08-17
excluded packagepackage0615-15920615-1592-39DDiscontinued 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 · 36 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-1592-39d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0615-1592-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-1592-39f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0615-1592-05f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-1592-392ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0615-1592-052ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-1592-39a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0615-1592-05a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-1592-39cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0615-1592-05cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-1592-39cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0615-1592-05cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-1592-39302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-1592-05302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-1592-39ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-1592-05ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-1592-390efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-1592-050efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-1592-39ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-1592-05ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-1592-39367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-1592-05367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-1592-39557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-1592-05557ba5c1ecfa…9c80585c8c6e…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
A018659-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB1986-10-24
A018659-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB1986-10-24

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-productTE code
A018659-001AB
A018659-002AB

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.

Product history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24caaa826d4ba7…
2026-08-18 06:07:402026-07A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24011fe1cb6892…
2026-02-19 14:30 UTC2026-02A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-2431067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-2431067a03dcf5…
2025-08-23 18:47 UTC2025-08A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-246a471c1ec25d…
2025-08-23 18:47 UTC2025-08A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-246a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-2403ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-2403ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-242680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-242680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-245bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-245bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24d06236e962d9…
2024-10-29 15:01 UTC2024-10A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-2479d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-2479d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-241e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-241e350fbaab3a…
2024-05-31 18:47 UTC2024-05A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-248072bd15b7f6…
2024-05-31 18:47 UTC2024-05A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-248072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-245c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-245c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-245d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-245d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-244b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-244b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-2474a2ff9319b5…
2019-12-13 00:20 UTC2019-12A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-2474a2ff9319b5…
2022-03-09 01:35 UTC2022-03A018659-001ALLOPURINOL100MGTABLET / ORALAB1986-10-24bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A018659-002ALLOPURINOL300MGTABLET / ORALAB1986-10-24bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A018659-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A018659-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A018659-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A018659-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A018659-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A018659-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A018659-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A018659-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A018659-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A018659-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A018659-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A018659-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A018659-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A018659-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A018659-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A018659-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A018659-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A018659-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A018659-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A018659-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A018659-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A018659-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A018659-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A018659-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A018659-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A018659-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A018659-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A018659-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A018659-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A018659-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A018659-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A018659-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A018659-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A018659-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A018659-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A018659-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A018659-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A018659-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A018659-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A018659-002AB1bb7c543d1eb4…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2
STARCH, PREGELATINIZED CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [NCS HEALTHCARE OF KY, INC DBA VANGARD LABS]2

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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLCardinal Health 107, LLCced59048-c147-4702-af32-2f9b517ed87a2026-07-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLCardinal Health 107, LLC1ce96b87-323d-40b6-a40b-32821e00d94c2026-04-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLBryant Ranch Prepack5dca2d4f-0e93-4d1a-8d9f-b9b72867c2422026-04-13Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLSafecor Health, LLCdbfb3bde-2274-43cc-b726-d4578ebdb5d42026-04-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.7c7eafa6-5411-470c-8a45-cfbc85d3e3352026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLMylan Pharmaceuticals Inc.bdbf5ad4-86f2-4e9c-a51a-fb0c7220c4802025-11-20Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLREMEDYREPACK INC.8f50e91e-66a7-4fd4-888a-9f1986aa661c2025-08-04Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLMylan Institutional Inc.994b3117-b83e-44d9-910c-1c3a26ef838e2025-07-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLAdvanced Rx Pharmacy of Tennessee, LLC15d758f9-2ec5-ecf5-e063-6394a90a7a2c2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLCoupler LLC65171cf0-8486-1ca6-e053-2991aa0ab91f2018-04-18Exact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLCaea483a7-4ce7-4fe5-936c-fd876b4fa3a82017-10-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLCae821c68-626a-474c-b81d-ce75d9795b3c2016-08-15Warnings, Adverse reactionsExact identifier
application applno (ANDA): 018659
application number: ANDA018659

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0615-1592-050061515920515 TABLET in 1 BLISTER PACK (0615-1592-05) 15 tablet2006-05-312021-07-31NoNoCurrent
0615-1592-390061515923930 TABLET in 1 BLISTER PACK (0615-1592-39) 30 tablet2006-02-282021-07-31NoNoCurrent