Allopurinol

Product NDC
53489-156
11-digit product format
534890156
Labeler code
53489
Product ID
53489-156_4c3692cf-dd55-f58c-e063-6394a90a1373
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA071450
Marketing category
ANDA
Marketing start
1987-01-09
Substance
ALLOPURINOL
Active strength
100 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
A071450-001ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB1987-01-09
A071450-002ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB1987-01-09

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A071450-001AB
A071450-002AB

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 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09caaa826d4ba7…
2026-08-18 06:07:402026-07A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0931067a03dcf5…
2025-08-23 18:47 UTC2025-08A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-096a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-096a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-092680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-092680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09d06236e962d9…
2024-10-29 15:01 UTC2024-10A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-091e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-091e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-098072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-098072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-095d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-095d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-094b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-094b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-0974a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-0974a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071450-001ALLOPURINOL300MGTABLET / ORALAB1987-01-09bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071450-002ALLOPURINOL100MGTABLET / ORALAB1987-01-09bb7c543d1eb4…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07A071450-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A071450-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A071450-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A071450-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A071450-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A071450-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A071450-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A071450-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A071450-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A071450-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A071450-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A071450-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A071450-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A071450-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A071450-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A071450-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A071450-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A071450-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A071450-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A071450-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A071450-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A071450-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A071450-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A071450-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A071450-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A071450-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A071450-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A071450-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A071450-002AB1bb7c543d1eb4…

Additional Listing Data#

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

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 · 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
fd8f8b8b-f25e-46e9-969a-65363b66e09bAvailable 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
53489-156-01Allopurinol100 in 1 BOTTLE, PLASTICTABLET10010
53489-156-02Allopurinol50 in 1 BOTTLE, PLASTICTABLET5010
53489-156-05Allopurinol500 in 1 BOTTLE, PLASTICTABLET50010
53489-156-10Allopurinol1000 in 1 BOTTLE, PLASTICTABLET100010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53489-156-01EA - Each53489-156e02e34c4-27a0-41fe-b90f-b15f6ebe467e12016-01-13
53489-156-05EA - Each53489-1566ac4661b-0fff-482a-b861-86e2054102bc12016-01-13
53489-156-10EA - Each53489-156fe1759f7-475e-4b84-b0b3-41b0ac8f774b12016-01-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AllopurinolACTIVE INGREDIENT63CZ7GJN5IALLOPURINOL TABLET [MUTUAL PHARMACEUTICAL]5
AllopurinolACTIVE MOIETY63CZ7GJN5IALLOPURINOL TABLET [MUTUAL PHARMACEUTICAL]5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53489-156ALLOPURINOL TABLET [SUN PHARMACEUTICAL INDUSTRIES, INC.]9Current NDC, Legacy NDC, 4 package rows20240216_fd8f8b8b-f25e-46e9-969a-65363b66e09b.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f1c11f74-1de2-484c-b40b-d0013e8fd01a2026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.f130c9c0-45d8-42bc-a040-04bb077671f82026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.b2ab2389-ccaf-487b-9985-50e3539e76172026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLPD-Rx Pharmaceuticals, Inc.211e47c6-85b9-43e8-9e07-6cc4b8f708a02026-08-07Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLSun Pharmaceutical Industries, Inc.fd8f8b8b-f25e-46e9-969a-65363b66e09b2026-07-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
ndc (product): 53489-156
AllopurinolALLOPURINOLBryant Ranch Prepack156d743c-6324-44db-9230-21f762d64cfd2026-06-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLNorthwind Health Company, LLCdf745f5f-7f05-205d-e053-2995a90a05a42026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLNorthwind Health Company, LLCf67d4aa7-6e5f-bba1-e053-2a95a90a11942025-12-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLProficient Rx LPb20c6ed4-6b94-4a1b-b448-e910856fa8252022-08-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLProficient Rx LP06cf0f4b-aef0-472e-b5c0-56e0c35354f22022-06-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLCbb8f09b6-c9f5-4deb-81e1-8d743e6221262019-03-26Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC3f5905f1-243e-4880-ad1c-d34064f173562019-01-09Warnings, Adverse reactionsExact identifier
application applno (ANDA): 071450
application number: ANDA071450

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSNf130c9c0-45d8-42bc-a040-04bb077671f818
197319allopurinol 100 MG Oral TabletSCDf130c9c0-45d8-42bc-a040-04bb077671f818
197319allopurinol 100 MG Oral TabletPSNfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197320allopurinol 300 MG Oral TabletPSNfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197319allopurinol 100 MG Oral TabletSCDfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197320allopurinol 300 MG Oral TabletSCDfd8f8b8b-f25e-46e9-969a-65363b66e09b10
197319allopurinol 100 MG Oral TabletPSNf67d4aa7-6e5f-bba1-e053-2a95a90a11943
197319allopurinol 100 MG Oral TabletPSNbfd3bd12-ebe7-486c-8338-824b05fff1b13
197319allopurinol 100 MG Oral TabletPSN06cf0f4b-aef0-472e-b5c0-56e0c35354f23
197319allopurinol 100 MG Oral TabletSCDbfd3bd12-ebe7-486c-8338-824b05fff1b13
197319allopurinol 100 MG Oral TabletSCDf67d4aa7-6e5f-bba1-e053-2a95a90a11943
197319allopurinol 100 MG Oral TabletSCD06cf0f4b-aef0-472e-b5c0-56e0c35354f23
197319allopurinol 100 MG Oral TabletPSN3f5905f1-243e-4880-ad1c-d34064f173562
197319allopurinol 100 MG Oral TabletSCD3f5905f1-243e-4880-ad1c-d34064f173562
197319allopurinol 100 MG Oral TabletPSN57fa94ed-b29e-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletPSN156d743c-6324-44db-9230-21f762d64cfd1
197319allopurinol 100 MG Oral TabletSCD57fa94ed-b29e-456a-e053-2a91aa0af4841
197319allopurinol 100 MG Oral TabletSCD156d743c-6324-44db-9230-21f762d64cfd1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53489-156-0153489015601100 TABLET in 1 BOTTLE, PLASTIC (53489-156-01) 100 tablet1987-01-090000-00-00NoNoCurrent
53489-156-025348901560250 TABLET in 1 BOTTLE, PLASTIC (53489-156-02) 50 tablet1987-01-090000-00-00NoNoCurrent
53489-156-0553489015605500 TABLET in 1 BOTTLE, PLASTIC (53489-156-05) 500 tablet1987-01-090000-00-00NoNoCurrent
53489-156-10534890156101000 TABLET in 1 BOTTLE, PLASTIC (53489-156-10) 1000 tablet1987-01-090000-00-00NoNoCurrent