Mercaptopurine

Product NDC
51407-983
11-digit product format
514070983
Labeler code
51407
Product ID
51407-983_4bae6ff1-db75-6704-e063-6294a90a7f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Mercaptopurine
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA040528
Marketing category
ANDA
Marketing start
2004-02-13
Substance
MERCAPTOPURINE
Active strength
50 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
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 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
A040528-001MERCAPTOPURINEMERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040528-001AB

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 UTC2026-02A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-1331067a03dcf5…
2025-08-23 18:47 UTC2025-08A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-136a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-1303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-132680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-135bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-1379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-131e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-138072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-135c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-135d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-134b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-1374a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-1387673890dc5c…
2021-03-12 10:30 UTC2021-03A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-135aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-138869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-133f01610625f2…
2019-09-15 20:21 UTC2019-09A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13b00525d2431f…
2019-07-19 19:46 UTC2019-07A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-136a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-131c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-139b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-133f0d92c62455…
2023-05-13 08:27 UTC2023-05A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13053a50430f4f…
2023-01-26 05:58 UTC2023-01A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-133bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-133a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040528-001MERCAPTOPURINE50MGTABLET / ORALABRS2004-02-13cb3db0bc1861…

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 UTC2026-02A040528-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040528-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040528-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040528-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040528-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040528-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040528-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040528-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040528-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040528-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040528-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040528-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040528-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040528-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040528-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040528-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040528-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040528-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040528-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040528-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040528-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040528-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040528-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040528-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040528-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040528-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040528-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040528-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040528-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040528-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040528-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040528-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040528-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040528-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040528-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040528-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040528-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040528-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040528-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040528-001AB1cb3db0bc1861…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MERCAPTOPURINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E7WED276I5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197931Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bae5ffb-a535-3fa0-e063-6294a90aa90aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf12bc23-c2fc-473d-b96b-09804993250cProduct name220251205
0792acb3-e7e2-462f-964b-46c22a0c6eb5Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-983-25Mercaptopurine250 in 1 BOTTLE, PLASTICTABLET2501

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-983-25EA - Each51407-983fd06aee6-b98c-41a4-a6cb-f956525e231512026-04-20

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MercaptopurineMERCAPTOPURINEGolden State Medical Supply, Inc.4bae5ffb-a535-3fa0-e063-6294a90aa90a2026-02-25Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040528
application number: ANDA040528
ndc (product): 51407-983
MercaptopurineMERCAPTOPURINEHikma Pharmaceuticals USA Inc.c3b5b8b0-bc5c-4ce9-bbdc-febba60c26582024-10-01Warnings, Adverse reactionsExact identifier
application applno (ANDA): 040528
application number: ANDA040528

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197931mercaptopurine 50 MG Oral TabletPSN4bae5ffb-a535-3fa0-e063-6294a90aa90a1
197931mercaptopurine 50 MG Oral TabletSCD4bae5ffb-a535-3fa0-e063-6294a90aa90a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-983-2551407098325250 TABLET in 1 BOTTLE, PLASTIC (51407-983-25) 250 tablet2026-01-19NoNoCurrent