Allopurinol

Product NDC
71335-1656
11-digit product format
713351656
Labeler code
71335
Product ID
71335-1656_060fac75-71ae-45b0-92d9-f5005e92a51f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071586
Marketing category
ANDA
Marketing start
2009-10-01
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

Source provenance: Browse the complete Orange Book source catalog.

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 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071586-001LOPURIN100MGTABLET / ORALAB1987-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071586-001LOPURIN100MGTABLET / ORALAB1987-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071586-001LOPURIN100MGTABLET / ORALAB1987-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071586-001LOPURIN100MGTABLET / ORALAB1987-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071586-001LOPURIN100MGTABLET / ORALAB1987-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071586-001LOPURIN100MGTABLET / ORALAB1987-04-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A071586-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071586-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071586-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071586-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071586-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071586-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071586-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071586-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071586-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071586-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071586-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071586-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071586-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071586-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071586-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071586-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071586-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071586-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071586-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071586-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071586-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071586-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071586-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071586-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071586-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071586-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071586-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071586-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071586-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071586-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071586-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071586-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071586-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071586-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071586-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071586-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071586-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071586-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A071586-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071586-001AB1cb3db0bc1861…

Additional Listing Data#

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

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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197319Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5a1bfae2-116f-4ef9-bb7b-3b69ac74df03Available 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
71335-1656-1Allopurinol100 in 1 BOTTLETABLET1003
71335-1656-2Allopurinol30 in 1 BOTTLETABLET303
71335-1656-3Allopurinol60 in 1 BOTTLETABLET603
71335-1656-4Allopurinol120 in 1 BOTTLETABLET1203
71335-1656-5Allopurinol20 in 1 BOTTLETABLET203
71335-1656-6Allopurinol90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1656ALLOPURINOL TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 6 package rows20250224_5a1bfae2-116f-4ef9-bb7b-3b69ac74df03.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
AllopurinolALLOPURINOLNorthwind Health Company, LLCfe06da1b-c493-e238-e053-6294a90a91952026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
AllopurinolALLOPURINOLDr. Reddy's Laboratories Limited19a138b8-d225-03e6-f762-abe71560204b2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
AllopurinolALLOPURINOLBryant Ranch Prepack5a1bfae2-116f-4ef9-bb7b-3b69ac74df032025-01-30Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586
ndc (product): 71335-1656
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC3dc4980c-8062-4239-a860-63888cabee462021-08-03Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071586
application number: ANDA071586

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN5a1bfae2-116f-4ef9-bb7b-3b69ac74df033
197319allopurinol 100 MG Oral TabletSCD5a1bfae2-116f-4ef9-bb7b-3b69ac74df033

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1656-171335165601100 TABLET in 1 BOTTLE (71335-1656-1) 100 tablet2025-01-300000-00-00NoNoCurrent
71335-1656-27133516560230 TABLET in 1 BOTTLE (71335-1656-2) 30 tablet2020-09-210000-00-00NoNoCurrent
71335-1656-37133516560360 TABLET in 1 BOTTLE (71335-1656-3) 60 tablet2020-11-110000-00-00NoNoCurrent
71335-1656-471335165604120 TABLET in 1 BOTTLE (71335-1656-4) 120 tablet2025-01-300000-00-00NoNoCurrent
71335-1656-57133516560520 TABLET in 1 BOTTLE (71335-1656-5) 20 tablet2025-01-300000-00-00NoNoCurrent
71335-1656-67133516560690 TABLET in 1 BOTTLE (71335-1656-6) 90 tablet2020-06-290000-00-00NoNoCurrent