Allopurinol

Product NDC
63629-1781
11-digit product format
636291781
Labeler code
63629
Product ID
63629-1781_cf8169e9-905c-44b3-8a4f-14c4f3edfc75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
NDA018877
Marketing category
NDA
Marketing start
2009-04-06
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 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N018877-001ALLOPURINOLALLOPURINOL300MGTABLET / 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
N018877-001AB

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 06:07:402026-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283f01610625f2…
2019-09-15 20:21 UTC2019-09N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018877-001ALLOPURINOL300MGTABLET / ORALAB1984-09-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018877-001ALLOPURINOL300MGTABLET / 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 06:07:402026-07N018877-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N018877-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N018877-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N018877-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N018877-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N018877-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N018877-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N018877-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N018877-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N018877-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N018877-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N018877-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N018877-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N018877-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N018877-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N018877-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N018877-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N018877-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N018877-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N018877-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N018877-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N018877-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N018877-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N018877-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N018877-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N018877-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N018877-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N018877-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N018877-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N018877-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N018877-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N018877-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N018877-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N018877-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N018877-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N018877-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N018877-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N018877-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N018877-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N018877-001AB1e64feba35796…

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
7003e410-b4ff-da07-5571-07e7e13f67e0Available 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
63629-1781-1Allopurinol30 in 1 BOTTLETABLET3013
63629-1781-2Allopurinol60 in 1 BOTTLETABLET6013
63629-1781-3Allopurinol100 in 1 BOTTLETABLET10013
63629-1781-4Allopurinol90 in 1 BOTTLETABLET9013
63629-1781-5Allopurinol20 in 1 BOTTLETABLET2013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1781-1EA - Each63629-17816c67b039-6517-4565-b039-23d4cdfd5ae112012-07-24
63629-1781-2EA - Each63629-17819b5528be-f05e-457d-b0fb-2627d2baeb7a12012-07-24
63629-1781-3EA - Each63629-17814b32ab13-2e06-407d-a45a-33eb85dce31412012-07-24
63629-1781-4EA - Each63629-1781bb6558fd-f71a-4b9b-b959-b096c2c2284312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JALLOPURINOL TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1781ALLOPURINOL TABLET [BRYANT RANCH PREPACK]13Current NDC, Legacy NDC, 5 package rows20240524_7003e410-b4ff-da07-5571-07e7e13f67e0.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLBryant Ranch Prepack7003e410-b4ff-da07-5571-07e7e13f67e02024-05-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
ndc (product): 63629-1781
AllopurinolALLOPURINOLActavis Pharma, Inc.a80fe56f-8d03-423f-8e2a-7ec8c9e5045b2024-04-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
AllopurinolALLOPURINOLProficient Rx LP0ca4baed-c5d8-4de4-ac17-6e5d1df15c032023-02-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC9b0e3f11-c02a-443d-806f-134c907ea3712022-12-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 018877
application number: NDA018877

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSN7003e410-b4ff-da07-5571-07e7e13f67e013
197320allopurinol 300 MG Oral TabletSCD7003e410-b4ff-da07-5571-07e7e13f67e013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1781-16362917810130 TABLET in 1 BOTTLE (63629-1781-1) 30 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-26362917810260 TABLET in 1 BOTTLE (63629-1781-2) 60 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-363629178103100 TABLET in 1 BOTTLE (63629-1781-3) 100 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-46362917810490 TABLET in 1 BOTTLE (63629-1781-4) 90 tablet2009-04-060000-00-00NoNoCurrent
63629-1781-56362917810520 TABLET in 1 BOTTLE (63629-1781-5) 20 tablet2009-04-060000-00-00NoNoCurrent