Allopurinol

Product NDC
51079-206
11-digit product format
510790206
Labeler code
51079
Product ID
51079-206_3a3943bc-5dca-3650-e063-6394a90afa1b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA018659
Marketing category
ANDA
Marketing start
1997-04-29
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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…

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2026-12-31

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
994b3117-b83e-44d9-910c-1c3a26ef838eAvailable 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
51079-206-01Allopurinol1 in 1 BLISTER PACKTABLET111
51079-206-20Allopurinol100 in 1 CARTONTABLET10011

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-206-01EA - Each51079-206dd5c5ae4-9610-46e1-9bba-482a247f02db12012-07-24
51079-206-17EA - Each51079-2061ffc82cd-7ea2-4ed8-8d29-f9f4053b05b312012-07-24
51079-206-19EA - Each51079-20622e20541-b1a7-4d6c-a0c1-f7e833d9e23b12012-07-24
51079-206-20EA - Each51079-206786202d7-3ecd-4333-bfde-3411329fd36512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [CARDINAL HEALTH]8
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [CARDINAL HEALTH]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [CARDINAL HEALTH]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [CARDINAL HEALTH]8
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [CARDINAL HEALTH]8
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [CARDINAL HEALTH]8
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [CARDINAL HEALTH]8
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [CARDINAL HEALTH]8
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-206ALLOPURINOL TABLET [MYLAN INSTITUTIONAL INC.]10Current NDC, Legacy NDC, 2 package rows20240920_994b3117-b83e-44d9-910c-1c3a26ef838e.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 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
ndc (product): 51079-206
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN1ce96b87-323d-40b6-a40b-32821e00d94c22
197320allopurinol 300 MG Oral TabletPSN1ce96b87-323d-40b6-a40b-32821e00d94c22
197319allopurinol 100 MG Oral TabletSCD1ce96b87-323d-40b6-a40b-32821e00d94c22
197320allopurinol 300 MG Oral TabletSCD1ce96b87-323d-40b6-a40b-32821e00d94c22
197319allopurinol 100 MG Oral TabletPSN994b3117-b83e-44d9-910c-1c3a26ef838e11
197320allopurinol 300 MG Oral TabletPSN994b3117-b83e-44d9-910c-1c3a26ef838e11
197319allopurinol 100 MG Oral TabletSCD994b3117-b83e-44d9-910c-1c3a26ef838e11
197320allopurinol 300 MG Oral TabletSCD994b3117-b83e-44d9-910c-1c3a26ef838e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-206-01510790206011 in 1 BLISTER PACKHistorical
51079-206-2051079020620100 BLISTER PACK in 1 CARTON (51079-206-20) / 1 TABLET in 1 BLISTER PACK (51079-206-01) 100 blister pack1997-04-290000-00-00NoNoCurrent