Allopurinol

Product NDC
0591-5543
11-digit product format
005915543
Labeler code
0591
Product ID
0591-5543_f7e04d88-1d9b-47e6-a9ad-deb08af3c098
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
NDA018832
Marketing category
NDA
Marketing start
2009-04-06
Marketing end
2027-04-30
Substance
ALLOPURINOL
Active strength
100 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
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
unfinished productproduct0591-5543UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0591-55430591-5543-00UNFINISHEDActive or certified unfinished drug listing2026-08-17
unfinished packagepackage0591-55430591-5543-77UNFINISHEDActive or certified unfinished drug listing2026-08-17
excluded packagepackage0591-55430591-5543-01DDiscontinued 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 · 54 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 21:27 UTC · source 2025-12-05unfinished productproducta6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0591-5543-77a6255e0c9aa5…a0211a219f2e…
2025-12-14 21:27 UTC · source 2025-12-05unfinished packagepackage0591-5543-00a6255e0c9aa5…a0211a219f2e…
2025-08-26 23:59 UTC · source 2025-08-26unfinished productproduct1d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0591-5543-771d862106b807…00c93037cd84…
2025-08-26 23:59 UTC · source 2025-08-26unfinished packagepackage0591-5543-001d862106b807…00c93037cd84…
2025-05-15 14:59 UTC · source 2025-05-14unfinished productproduct390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0591-5543-77390b4c401c3f…2c692c2daee3…
2025-05-15 14:59 UTC · source 2025-05-14unfinished packagepackage0591-5543-00390b4c401c3f…2c692c2daee3…
2025-04-01 07:37 UTC · source 2025-03-31unfinished productproducte30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0591-5543-77e30019b0c005…a3f0b14938b7…
2025-04-01 07:37 UTC · source 2025-03-31unfinished packagepackage0591-5543-00e30019b0c005…a3f0b14938b7…
2025-03-01 13:19 UTC · source 2025-02-28unfinished productproductbbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0591-5543-77bbbc9f937eca…946b9c97cf81…
2025-03-01 13:19 UTC · source 2025-02-28unfinished packagepackage0591-5543-00bbbc9f937eca…946b9c97cf81…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductf268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0591-5543-77f268b84574a6…26285f5ac5df…
2025-02-27 05:24 UTC · source 2025-02-26unfinished packagepackage0591-5543-00f268b84574a6…26285f5ac5df…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductf764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0591-5543-77f764e8902f78…92046438deef…
2025-02-01 13:13 UTC · source 2025-01-31unfinished packagepackage0591-5543-00f764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproduct68b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0591-5543-7768b1e3bced9e…98a755eb8bc6…
2025-01-20 13:05 UTC · source 2025-01-17unfinished packagepackage0591-5543-0068b1e3bced9e…98a755eb8bc6…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproduct05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0591-5543-7705c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage0591-5543-0005c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproduct48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage0591-5543-7748b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage0591-5543-0048b4f40e6753…c7c7a00d2afa…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproduct27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage0591-5543-7727f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage0591-5543-0027f29a85d7e4…1372111e901f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproduct8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage0591-5543-778d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage0591-5543-008d62ce987f31…9fe9ef23e30d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage0591-5543-00d1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproduct50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage0591-5543-0050b4072663b7…eae3003ed65e…
2022-04-09 23:13 UTC · source 2022-04-08unfinished productproduct906f6e251498…bf70b80e44f0…
2022-04-09 23:13 UTC · source 2022-04-08unfinished packagepackage0591-5543-00906f6e251498…bf70b80e44f0…
2021-12-27 23:28 UTC · source 2021-12-27unfinished productproduct6db9cb8d1e19…3449e1ec5b70…
2021-12-27 23:28 UTC · source 2021-12-27unfinished packagepackage0591-5543-006db9cb8d1e19…3449e1ec5b70…
2021-02-18 23:40 UTC · source 2021-02-18unfinished productproduct8fc7167e32ce…e96bbc724034…
2021-02-18 23:40 UTC · source 2021-02-18unfinished packagepackage0591-5543-008fc7167e32ce…e96bbc724034…
2020-12-18 03:04 UTC · source 2020-12-17unfinished productproduct4184dd79f89f…545327b3e20f…
2020-12-18 03:04 UTC · source 2020-12-17unfinished packagepackage0591-5543-004184dd79f89f…545327b3e20f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished productproduct4bd3596a7b87…5c64c6f6865f…
2020-06-10 20:45 UTC · source 2020-06-10unfinished packagepackage0591-5543-004bd3596a7b87…5c64c6f6865f…
2019-12-08 06:16 UTC · source 2019-12-05unfinished productproduct263afe128892…91768de4ddbe…
2019-12-08 06:16 UTC · source 2019-12-05unfinished packagepackage0591-5543-00263afe128892…91768de4ddbe…
2019-06-01 22:24 UTC · source 2019-05-30unfinished productproduct5b2001dcd8f5…54b53d4dc9e4…
2019-06-01 22:24 UTC · source 2019-05-30unfinished packagepackage0591-5543-005b2001dcd8f5…54b53d4dc9e4…

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

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018832-002ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB1984-09-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N018832-002AB

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 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018832-002ALLOPURINOL100MGTABLET / ORALAB1984-09-28e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N018832-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018832-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018832-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018832-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018832-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018832-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018832-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018832-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018832-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018832-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018832-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018832-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018832-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018832-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018832-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018832-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018832-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018832-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018832-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018832-002AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018832-002AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018832-002AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018832-002AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018832-002AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018832-002AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018832-002AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018832-002AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018832-002AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018832-002AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018832-002AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018832-002AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018832-002AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018832-002AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018832-002AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018832-002AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018832-002AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018832-002AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018832-002AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018832-002AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018832-002AB1e64feba35796…

Additional Listing Data#

Finished product
Yes
Brand name base
Allopurinol

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
a80fe56f-8d03-423f-8e2a-7ec8c9e5045bAvailable 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
0591-5543-01Allopurinol100 in 1 BOTTLE, PLASTICTABLET10016
0591-5543-10Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0591-5543-01EA - Each0591-55434902afaa-fd1e-4b4d-bc65-83052b01ef9612012-07-24
0591-5543-10EA - Each0591-554398fc485a-436e-4b89-9973-3bbcfd1a7d2012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]65
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [AMERICAN HEALTH PACKAGING]4
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [WATSON LABORATORIES, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [PHYSICIANS TOTAL CARE, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [PROFICIENT RX LP]1
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [PROFICIENT RX LP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [PROFICIENT RX LP]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [PROFICIENT RX LP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [PROFICIENT RX LP]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [PROFICIENT RX LP]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [STATE OF FLORIDA DOH CENTRAL PHARMACY]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [AIDAREX PHARMACEUTICALS LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [PROFICIENT RX LP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0591-5543ALLOPURINOL TABLET [ACTAVIS PHARMA, INC.]15Current NDC, Legacy NDC, 2 package rows20240606_a80fe56f-8d03-423f-8e2a-7ec8c9e5045b.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLActavis Pharma, Inc.a80fe56f-8d03-423f-8e2a-7ec8c9e5045b2024-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018832
application number: NDA018832
ndc (product): 0591-5543
AllopurinolALLOPURINOLProficient Rx LP0ca4baed-c5d8-4de4-ac17-6e5d1df15c032023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018832
application number: NDA018832

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNa80fe56f-8d03-423f-8e2a-7ec8c9e5045b16
197320allopurinol 300 MG Oral TabletPSNa80fe56f-8d03-423f-8e2a-7ec8c9e5045b16
197319allopurinol 100 MG Oral TabletSCDa80fe56f-8d03-423f-8e2a-7ec8c9e5045b16
197320allopurinol 300 MG Oral TabletSCDa80fe56f-8d03-423f-8e2a-7ec8c9e5045b16
197319allopurinol 100 MG Oral TabletPSN632baede-6ade-450e-afa3-50a6cf1f9c9110
197320allopurinol 300 MG Oral TabletPSN632baede-6ade-450e-afa3-50a6cf1f9c9110
197319allopurinol 100 MG Oral TabletSCD632baede-6ade-450e-afa3-50a6cf1f9c9110
197320allopurinol 300 MG Oral TabletSCD632baede-6ade-450e-afa3-50a6cf1f9c9110
197319allopurinol 100 MG Oral TabletPSN0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197320allopurinol 300 MG Oral TabletPSN0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197319allopurinol 100 MG Oral TabletSCD0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197320allopurinol 300 MG Oral TabletSCD0ca4baed-c5d8-4de4-ac17-6e5d1df15c036
197319allopurinol 100 MG Oral TabletPSN4fa7df0b-78ee-4bad-e054-00144ff8d46c3
197319allopurinol 100 MG Oral TabletSCD4fa7df0b-78ee-4bad-e054-00144ff8d46c3
197319allopurinol 100 MG Oral TabletPSNe1f42971-8169-4053-9857-585cef2ba7b02
197320allopurinol 300 MG Oral TabletPSNe1f42971-8169-4053-9857-585cef2ba7b02
197319allopurinol 100 MG Oral TabletSCDe1f42971-8169-4053-9857-585cef2ba7b02
197320allopurinol 300 MG Oral TabletSCDe1f42971-8169-4053-9857-585cef2ba7b02
197319allopurinol 100 MG Oral TabletPSNc9a01871-bbf8-4b31-9b9b-9fa8c0997b291
197319allopurinol 100 MG Oral TabletPSNda5833e4-1a6a-4978-bc9e-3045f774922a1
197319allopurinol 100 MG Oral TabletPSNc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197319allopurinol 100 MG Oral TabletPSNa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197320allopurinol 300 MG Oral TabletPSNda5833e4-1a6a-4978-bc9e-3045f774922a1
197320allopurinol 300 MG Oral TabletPSNc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197320allopurinol 300 MG Oral TabletPSNa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197319allopurinol 100 MG Oral TabletSCDc87fceaa-0e56-4042-95a2-08e7c0d6bc471
197319allopurinol 100 MG Oral TabletSCDc9a01871-bbf8-4b31-9b9b-9fa8c0997b291
197319allopurinol 100 MG Oral TabletSCDda5833e4-1a6a-4978-bc9e-3045f774922a1
197319allopurinol 100 MG Oral TabletSCDa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197320allopurinol 300 MG Oral TabletSCDa0c9fff0-f0ba-4bfe-ac88-afbfe31fcf681
197320allopurinol 300 MG Oral TabletSCDda5833e4-1a6a-4978-bc9e-3045f774922a1
197320allopurinol 300 MG Oral TabletSCDc87fceaa-0e56-4042-95a2-08e7c0d6bc471

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0591-5543-000059155430031700 TABLET in 1 BAG (0591-5543-00)31700 tablet06-APR-09Current
0591-5543-0100591554301100 TABLET in 1 BOTTLE, PLASTIC (0591-5543-01) 100 tablet2009-04-062026-05-31NoNoCurrent
0591-5543-10005915543101000 TABLET in 1 BOTTLE, PLASTIC (0591-5543-10) 1000 tablet2009-04-062027-04-30NoNoCurrent
0591-5543-770059155437738088 TABLET in 1 CONTAINER (0591-5543-77)38088 tablet11-JUN-24Current