Allopurinol

Product NDC
55111-730
Requested package NDC
55111-730-05
11-digit product format
551110730
Labeler code
55111
Product ID
55111-730_c3be239e-a0b5-fb8d-2ae6-372cef6fa362
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA071587
Marketing category
ANDA
Marketing start
2009-10-01
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 1.

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
A071587-001LOPURINALLOPURINOL300MGTABLET / ORALAB1987-04-02

Therapeutic equivalence codes#

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

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

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 · 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 UTC2026-02A071587-001LOPURIN300MGTABLET / 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…
2022-09-29 23:25 UTC2022-09A071587-001LOPURIN300MGTABLET / ORALAB1987-04-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071587-001LOPURIN300MGTABLET / 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 UTC2026-02A071587-001AB1011fe1cb6892…
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…
2022-09-29 23:25 UTC2022-09A071587-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A071587-001AB1cb3db0bc1861…

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 · 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
19a138b8-d225-03e6-f762-abe71560204bAvailable 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
55111-730-01Allopurinol100 in 1 BOTTLETABLET10014
55111-730-05Allopurinol500 in 1 BOTTLETABLET50014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-730-01EA - Each55111-730c58e43e4-2a71-445a-bfd4-d4f4b74c16df12012-07-24
55111-730-05EA - Each55111-7300286ddf1-2241-485f-a758-76eb8d20040f12012-07-24
55111-730-10EA - Each55111-7301c2402d7-7ee0-4857-930a-191b9be7feed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllopurinolACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
AllopurinolACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
LactoseINACTIVE INGREDIENTJ2B2A4N98GALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
Magnesium stearateINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
povidoneINACTIVE INGREDIENTFZ989GH94EALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]9
ALLOPURINOLACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
AllopurinolACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
ALLOPURINOLACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
AllopurinolACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
LACTOSEINACTIVE INGREDIENTJ2B2A4N98GALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
LactoseINACTIVE INGREDIENTJ2B2A4N98GALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
Magnesium stearateINACTIVE INGREDIENT70097M6I30ALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [BLENHEIM PHARMACAL, INC.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1
STARCH, POTATOINACTIVE INGREDIENT8I089SAH3TALLOPURINOL TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55111-730ALLOPURINOL TABLET [DR. REDDY'S LABORATORIES LIMITED]12Current NDC, Legacy NDC, 2 package rows20241222_19a138b8-d225-03e6-f762-abe71560204b.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
AllopurinolALLOPURINOLDr. Reddy's Laboratories Limited19a138b8-d225-03e6-f762-abe71560204b2025-09-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071587
application number: ANDA071587
ndc (package): 55111-730-05
ndc (product): 55111-730
ndc11 (package): 55111073005
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
197319allopurinol 100 MG Oral TabletPSN19a138b8-d225-03e6-f762-abe71560204b14
197320allopurinol 300 MG Oral TabletPSN19a138b8-d225-03e6-f762-abe71560204b14
197319allopurinol 100 MG Oral TabletSCD19a138b8-d225-03e6-f762-abe71560204b14
197320allopurinol 300 MG Oral TabletSCD19a138b8-d225-03e6-f762-abe71560204b14
197320allopurinol 300 MG Oral TabletPSN278df77c-3a9c-4c7d-ba8f-eb33f6335ef44
197320allopurinol 300 MG Oral TabletSCD278df77c-3a9c-4c7d-ba8f-eb33f6335ef44
197320allopurinol 300 MG Oral TabletPSNda814597-50e6-48fa-e053-2995a90ab21b3
197320allopurinol 300 MG Oral TabletSCDda814597-50e6-48fa-e053-2995a90ab21b3
197320allopurinol 300 MG Oral TabletPSN147e8c8b-4883-1e43-e054-00144ff8d46c1
197320allopurinol 300 MG Oral TabletSCD147e8c8b-4883-1e43-e054-00144ff8d46c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-730-0555111073005500 TABLET in 1 BOTTLE (55111-730-05) 500 tablet2009-10-010000-00-00NoNoCurrent