Allopurinol

Product NDC
51655-782
11-digit product format
516550782
Labeler code
51655
Product ID
51655-782_4a7afcf6-0537-77fe-e063-6294a90a3930
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Northwind Health Company, LLC
Application
ANDA071587
Marketing category
ANDA
Marketing start
2021-08-04
Substance
ALLOPURINOL
Active strength
300 mg/1
Pharmacologic classes
Xanthine Oxidase Inhibitor [EPC], Xanthine Oxidase Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
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
A071587-001LOPURINALLOPURINOL300MGTABLET / ORALAB1987-04-02
A071587-002LOPURINALLOPURINOL100MGTABLET / ORALAB1987-04-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071587-001AB
A071587-002AB

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02caaa826d4ba7…
2026-08-18 06:07:402026-07A071587-002LOPURIN100MGTABLET / ORALAB1987-04-02caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A071587-001LOPURIN300MGTABLET / ORALAB1987-04-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071587-001LOPURIN300MGTABLET / ORALAB1987-04-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071587-001LOPURIN300MGTABLET / ORALAB1987-04-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071587-001LOPURIN300MGTABLET / ORALAB1987-04-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071587-001LOPURIN300MGTABLET / ORALAB1987-04-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071587-001LOPURIN300MGTABLET / ORALAB1987-04-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071587-001LOPURIN300MGTABLET / ORALAB1987-04-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071587-001LOPURIN300MGTABLET / ORALAB1987-04-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071587-001LOPURIN300MGTABLET / ORALAB1987-04-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071587-001LOPURIN300MGTABLET / ORALAB1987-04-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A071587-001LOPURIN300MGTABLET / ORALAB1987-04-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-023f01610625f2…
2019-09-15 20:21 UTC2019-09A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071587-001LOPURIN300MGTABLET / ORALAB1987-04-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071587-001LOPURIN300MGTABLET / ORALAB1987-04-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071587-001LOPURIN300MGTABLET / ORALAB1987-04-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071587-001LOPURIN300MGTABLET / ORALAB1987-04-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A071587-001LOPURIN300MGTABLET / ORALAB1987-04-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071587-001LOPURIN300MGTABLET / ORALAB1987-04-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071587-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071587-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071587-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071587-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071587-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071587-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071587-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071587-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071587-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071587-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071587-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071587-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071587-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071587-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071587-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071587-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071587-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071587-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071587-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071587-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071587-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A071587-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A071587-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A071587-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A071587-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A071587-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A071587-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A071587-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A071587-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A071587-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A071587-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A071587-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A071587-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A071587-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A071587-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A071587-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A071587-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A071587-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A071587-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A071587-001AB1f41ea6bd6efb…

Additional Listing Data#

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

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
da814597-50e6-48fa-e053-2995a90ab21bAvailable 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
51655-782-26Allopurinol90 in 1 BOTTLE, PLASTICTABLET903
51655-782-52Allopurinol30 in 1 BOTTLE, PLASTICTABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51655-782ALLOPURINOL TABLET [NORTHWIND PHARMACEUTICALS]1Current NDC, 2 package rows20230221_da814597-50e6-48fa-e053-2995a90ab21b.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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLNorthwind Health Company, LLCda814597-50e6-48fa-e053-2995a90ab21b2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071587
application number: ANDA071587
ndc (product): 51655-782
AllopurinolALLOPURINOLDr. Reddy's Laboratories Limited19a138b8-d225-03e6-f762-abe71560204b2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071587
application number: ANDA071587
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC278df77c-3a9c-4c7d-ba8f-eb33f6335ef42022-05-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071587
application number: ANDA071587

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197320allopurinol 300 MG Oral TabletPSNda814597-50e6-48fa-e053-2995a90ab21b3
197320allopurinol 300 MG Oral TabletSCDda814597-50e6-48fa-e053-2995a90ab21b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51655-782-265165507822690 TABLET in 1 BOTTLE, PLASTIC (51655-782-26) 90 tablet2022-07-06NoNoCurrent
51655-782-525165507825230 TABLET in 1 BOTTLE, PLASTIC (51655-782-52) 30 tablet2021-08-04NoNoCurrent