Allopurinol

Product NDC
0603-2115
11-digit product format
006032115
Labeler code
0603
Product ID
0603-2115_bb93f828-90b4-4844-9256-f4f964243818
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Par Health USA, LLC
Application
ANDA075798
Marketing category
ANDA
Marketing start
2003-06-27
Substance
ALLOPURINOL
Active strength
100 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

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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0603-21150603-2115-02DDiscontinued by firm2026-08-17
excluded packagepackage0603-21150603-2115-04DDiscontinued by firm2026-08-17
excluded packagepackage0603-21150603-2115-28DDiscontinued by firm2026-08-17
excluded packagepackage0603-21150603-2115-93DDiscontinued 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 · 51 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-2115-93DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-2115-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-2115-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0603-2115-28DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-2115-93DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-2115-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-2115-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0603-2115-28DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-2115-93DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-2115-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-2115-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0603-2115-28DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-2115-93DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-2115-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-2115-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0603-2115-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-2115-93DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-2115-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-2115-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0603-2115-28DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-2115-93DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-2115-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-2115-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0603-2115-28DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-2115-93DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-2115-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-2115-04DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0603-2115-28DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-2115-93DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-2115-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-2115-04DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0603-2115-28DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-2115-93DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-2115-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-2115-04DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0603-2115-28DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-2115-04DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-2115-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-2115-93DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0603-2115-28DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-2115-04DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-2115-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-2115-93DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0603-2115-28DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-2115-04DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-2115-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-2115-93DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0603-2115-28DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0603-2115-32IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage0603-2115-21IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…

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
A075798-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2003-06-27
A075798-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2003-06-27

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A075798-001AB
A075798-002AB

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 06:07:402026-07A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27caaa826d4ba7…
2026-08-18 06:07:402026-07A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-2731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-276a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-276a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-2703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-2703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-272680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-272680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-275bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-275bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27d06236e962d9…
2024-10-29 15:01 UTC2024-10A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-2779d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-2779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-271e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-271e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-278072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-278072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-275c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-275c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-275d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-275d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-274b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-274b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-2774a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-2774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075798-001ALLOPURINOL100MGTABLET / ORALAB2003-06-27bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075798-002ALLOPURINOL300MGTABLET / ORALAB2003-06-27bb7c543d1eb4…

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 06:07:402026-07A075798-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A075798-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A075798-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075798-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075798-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075798-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075798-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075798-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075798-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075798-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075798-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075798-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075798-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075798-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075798-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075798-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075798-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075798-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075798-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075798-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075798-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075798-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075798-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A075798-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075798-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A075798-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075798-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A075798-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A075798-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A075798-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075798-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A075798-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A075798-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A075798-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A075798-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A075798-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A075798-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A075798-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A075798-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A075798-002AB1bb7c543d1eb4…

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALLOPURINOL100 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
fbac3b4f-dc23-4359-ac3f-2b3fdde41af2Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
0603-2115-022022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-022022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-042022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-042022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-212022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-212022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-282022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-282022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-322022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-322022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-932022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-932022-09-16These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-022022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-022022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-042022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-042022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-212022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-212022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-282022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-282022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-322022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-322022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-932022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966
0603-2115-932022-07-29These highlights do not include all the information needed to use ALLOPURINOL TABLETS safely and effectively. See full prescribing information for ALLOPURINOL TABLETS . ALLOPURINOL tablets for oral use Initial U.S. Approval:1966

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0603-2115-02Allopurinol90 in 1 BOTTLE, PLASTICTABLET9034
0603-2115-04Allopurinol180 in 1 BOTTLE, PLASTICTABLET18034
0603-2115-21Allopurinol100 in 1 BOTTLE, PLASTICTABLET10034
0603-2115-28Allopurinol500 in 1 BOTTLE, PLASTICTABLET50034
0603-2115-32Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100034
0603-2115-93Allopurinol3000 in 1 BOTTLE, PLASTICTABLET300034

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0603-2115-02EA - Each0603-211523d1fa4f-faba-4a6a-b810-5a803b4c3d2c12012-07-24
0603-2115-04EA - Each0603-2115e6f5f42c-1b75-4e25-98a3-35a3f625a32412012-07-24
0603-2115-21EA - Each0603-21151d81a29d-c01d-44f9-adca-33e0273b039112012-07-24
0603-2115-32EA - Each0603-2115150bb196-6537-4d61-8a68-8b7acf8d3dc612012-07-24
0603-2115-93EA - Each0603-2115b03ad957-edf1-46cc-99f2-b62fb5e81fd612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [QUALITEST PHARMACEUTICALS]10
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL (ALLOPURINOL) TABLET [PD-RX PHARMACEUTICALS, INC.]6
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]2
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [STAT RX USA LLC]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [STAT RX USA LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [STAT RX USA LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [STAT RX USA LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [STAT RX USA LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ALLOPURINOL TABLET [STAT RX USA LLC]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ALLOPURINOL TABLET [STAT RX USA LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0603-2115ALLOPURINOL TABLET [ENDO USA, INC.]33Current NDC, Legacy NDC, 6 package rows20241212_fbac3b4f-dc23-4359-ac3f-2b3fdde41af2.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLCardinal Health 107, LLCb6c5b5c0-b1cb-44c0-a849-5d317e6fa3002026-07-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLMajor Pharmaceuticals8c0f5af5-a453-4641-933f-ccb2625fca392026-06-24Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLNCS HealthCare of KY, LLC dba Vangard Labs1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c32026-01-23Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLREMEDYREPACK INC.4dbced9a-ef6f-455e-8d5d-b635409521db2025-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack73a374a6-ea1a-40a1-b6eb-d42654df08952024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepackf91c2183-e41d-45bc-87aa-edfca5eebac52024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack005048dd-844f-468c-bf56-1a09727e34772024-07-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepack90912dd4-5abf-4fd3-8fc1-3afd057b743f2024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLBryant Ranch Prepacke84cd8df-79d8-449f-ace2-5a4de1cdaf512024-04-08Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
AllopurinolALLOPURINOLPar Health USA, LLCfbac3b4f-dc23-4359-ac3f-2b3fdde41af22024-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075798
application number: ANDA075798
ndc (product): 0603-2115

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNf91c2183-e41d-45bc-87aa-edfca5eebac5105
197319allopurinol 100 MG Oral TabletSCDf91c2183-e41d-45bc-87aa-edfca5eebac5105
197319allopurinol 100 MG Oral TabletPSN90912dd4-5abf-4fd3-8fc1-3afd057b743f103
197319allopurinol 100 MG Oral TabletSCD90912dd4-5abf-4fd3-8fc1-3afd057b743f103
197319allopurinol 100 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletPSN1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197319allopurinol 100 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197320allopurinol 300 MG Oral TabletSCD1da7d9d4-ed94-4fe6-827a-6f4b3bdce3c336
197319allopurinol 100 MG Oral TabletPSNfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197320allopurinol 300 MG Oral TabletPSNfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197319allopurinol 100 MG Oral TabletSCDfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197320allopurinol 300 MG Oral TabletSCDfbac3b4f-dc23-4359-ac3f-2b3fdde41af234
197319allopurinol 100 MG Oral TabletPSN4fe4f58d-975d-1f7d-e054-00144ff8d46c3
197319allopurinol 100 MG Oral TabletSCD4fe4f58d-975d-1f7d-e054-00144ff8d46c3
197319allopurinol 100 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletPSN548f6fbb-155f-45ff-ab44-0a70adad44242
197319allopurinol 100 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242
197320allopurinol 300 MG Oral TabletSCD548f6fbb-155f-45ff-ab44-0a70adad44242
197319allopurinol 100 MG Oral TabletPSN57fa94ed-b29c-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletPSN8afe0c86-00c5-452f-b7b4-7ae81b7da1311
197319allopurinol 100 MG Oral TabletPSN266cb5ff-bf9d-99bb-e063-6394a90a8f541
197319allopurinol 100 MG Oral TabletSCD57fa94ed-b29c-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletSCD8afe0c86-00c5-452f-b7b4-7ae81b7da1311
197319allopurinol 100 MG Oral TabletSCD266cb5ff-bf9d-99bb-e063-6394a90a8f541

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0603-2115-020060321150290 in 1 BOTTLE, PLASTICHistorical
0603-2115-0400603211504180 in 1 BOTTLE, PLASTICHistorical
0603-2115-2100603211521100 TABLET in 1 BOTTLE, PLASTIC (0603-2115-21) 100 tablet2003-06-270000-00-00NoNoCurrent
0603-2115-2800603211528500 in 1 BOTTLE, PLASTICHistorical
0603-2115-32006032115321000 TABLET in 1 BOTTLE, PLASTIC (0603-2115-32) 1000 tablet2003-06-270000-00-00NoNoCurrent
0603-2115-93006032115933000 in 1 BOTTLE, PLASTICHistorical