Allopurinol

Product NDC
16729-134
11-digit product format
167290134
Labeler code
16729
Product ID
16729-134_40820fd2-3759-d43f-e063-6394a90a7c93
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
allopurinol
Dosage form
TABLET
Route
ORAL
Labeler
Accord Healthcare Inc.
Application
ANDA203154
Marketing category
ANDA
Marketing start
2015-04-29
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 · 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
A203154-001ALLOPURINOLALLOPURINOL100MGTABLET / ORALAB2013-05-06
A203154-002ALLOPURINOLALLOPURINOL300MGTABLET / ORALAB2013-05-06

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203154-001AB
A203154-002AB

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 06:07:402026-07A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06caaa826d4ba7…
2026-08-18 06:07:402026-07A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-066a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-062680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06d06236e962d9…
2024-10-29 15:01 UTC2024-10A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-061e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-068072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-002ALLOPURINOL300MGTABLET / ORALABRS2013-05-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-065d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-064b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-0674a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203154-001ALLOPURINOL100MGTABLET / ORALAB2013-05-06bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203154-002ALLOPURINOL300MGTABLET / ORALAB2013-05-06bb7c543d1eb4…

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 06:07:402026-07A203154-001AB1caaa826d4ba7…
2026-08-18 06:07:402026-07A203154-002AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203154-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A203154-002AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203154-002AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203154-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A203154-002AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203154-002AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203154-002AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203154-002AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203154-002AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203154-002AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203154-002AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203154-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A203154-002AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203154-002AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203154-002AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203154-002AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203154-001AB18072bd15b7f6…
2024-05-31 18:47 UTC2024-05A203154-002AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-001AB15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203154-002AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203154-001AB15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04A203154-002AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203154-001AB14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04A203154-002AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203154-001AB174a2ff9319b5…
2019-12-13 00:20 UTC2019-12A203154-002AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203154-001AB1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03A203154-002AB1bb7c543d1eb4…

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 · 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
682dd8b8-fc6e-47c5-95b7-82d7ad96b750Available 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
16729-134-01Allopurinol100 in 1 BOTTLETABLET10013
16729-134-10Allopurinol30 in 1 BOTTLETABLET3013
16729-134-16Allopurinol500 in 1 BOTTLETABLET50013
16729-134-17Allopurinol1000 in 1 BOTTLETABLET100013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
16729-134-01EA - Each16729-13417ff7548-6414-46b0-a84d-3702c791c10012015-06-09
16729-134-16EA - Each16729-134a8a871e3-9eb5-408c-953d-bff95074e92e12016-06-14

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
16729-134ALLOPURINOL TABLET ALLOPURINOL TABLET [ACCORD HEALTHCARE INC.]12Current NDC, Legacy NDC, 4 package rows20240216_682dd8b8-fc6e-47c5-95b7-82d7ad96b750.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 · 10 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AllopurinolALLOPURINOLBryant Ranch Prepack3bcd1381-34d9-4fa5-bfc5-2566cb7a76382026-05-21Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLBryant Ranch Prepack76ed9122-b845-423b-a6d5-a47b317433172026-05-19Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLPreferred Pharmaceuticals Inc.eb1b1aa6-cbd3-4b06-b9f9-9a0779a2da082026-02-18Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLNorthwind Health Company, LLCf3198e1b-6344-ad96-e053-2995a90a4aaf2026-01-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLAccord Healthcare Inc.682dd8b8-fc6e-47c5-95b7-82d7ad96b7502025-10-06Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
ndc (product): 16729-134
AllopurinolALLOPURINOLAdvanced Rx Pharmacy of Tennessee, LLCec09fbcf-6e20-8438-e053-2a95a90a63762024-12-31Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLNuCare Pharmaceuticals, Inc.44bcc8df-a803-010f-e054-00144ff88e882024-08-14Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLA-S Medication Solutions71accbc4-8bd7-4d22-ae53-c7b044a15ffa2024-04-11Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLAphena Pharma Solutions - Tennessee, LLC0155151c-6e84-4f9b-9233-60ffa74832932022-11-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154
AllopurinolALLOPURINOLProficient Rx LPd94f6643-621f-45ed-b2dc-26f84c5626ae2020-02-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 203154
application number: ANDA203154

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197319allopurinol 100 MG Oral TabletPSN3bcd1381-34d9-4fa5-bfc5-2566cb7a7638103
197319allopurinol 100 MG Oral TabletSCD3bcd1381-34d9-4fa5-bfc5-2566cb7a7638103
197319allopurinol 100 MG Oral TabletPSNf3198e1b-6344-ad96-e053-2995a90a4aaf14
197319allopurinol 100 MG Oral TabletSCDf3198e1b-6344-ad96-e053-2995a90a4aaf14
197319allopurinol 100 MG Oral TabletPSN682dd8b8-fc6e-47c5-95b7-82d7ad96b75013
197320allopurinol 300 MG Oral TabletPSN682dd8b8-fc6e-47c5-95b7-82d7ad96b75013
197319allopurinol 100 MG Oral TabletSCD682dd8b8-fc6e-47c5-95b7-82d7ad96b75013
197320allopurinol 300 MG Oral TabletSCD682dd8b8-fc6e-47c5-95b7-82d7ad96b75013
197319allopurinol 100 MG Oral TabletPSN71accbc4-8bd7-4d22-ae53-c7b044a15ffa9
197319allopurinol 100 MG Oral TabletSCD71accbc4-8bd7-4d22-ae53-c7b044a15ffa9
197319allopurinol 100 MG Oral TabletPSN44bcc8df-a803-010f-e054-00144ff88e887
197319allopurinol 100 MG Oral TabletSCD44bcc8df-a803-010f-e054-00144ff88e887
197319allopurinol 100 MG Oral TabletPSN67604124-399e-7baf-e053-2a91aa0a8ee83
197320allopurinol 300 MG Oral TabletPSN67604124-399e-7baf-e053-2a91aa0a8ee83
197319allopurinol 100 MG Oral TabletSCD67604124-399e-7baf-e053-2a91aa0a8ee83
197320allopurinol 300 MG Oral TabletSCD67604124-399e-7baf-e053-2a91aa0a8ee83
197319allopurinol 100 MG Oral TabletPSNbfdf2d34-e988-8543-e053-2a95a90a795d1
197319allopurinol 100 MG Oral TabletPSNdb496bce-6609-90dc-e053-2995a90a1efc1
197319allopurinol 100 MG Oral TabletPSN0155151c-6e84-4f9b-9233-60ffa74832931
197319allopurinol 100 MG Oral TabletSCD0155151c-6e84-4f9b-9233-60ffa74832931
197319allopurinol 100 MG Oral TabletSCDbfdf2d34-e988-8543-e053-2a95a90a795d1
197319allopurinol 100 MG Oral TabletSCDdb496bce-6609-90dc-e053-2995a90a1efc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
16729-134-0116729013401100 TABLET in 1 BOTTLE (16729-134-01) 100 tablet2015-04-290000-00-00NoNoCurrent
16729-134-101672901341030 in 1 BOTTLEHistorical
16729-134-1616729013416500 TABLET in 1 BOTTLE (16729-134-16) 500 tablet2016-06-140000-00-00NoNoCurrent
16729-134-17167290134171000 in 1 BOTTLEHistorical