mercaptopurine

Product NDC
49884-922
11-digit product format
498840922
Labeler code
49884
Product ID
49884-922_4d29e7e8-7d71-403f-aae1-ea79e1e0e0ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
mercaptopurine
Dosage form
TABLET
Route
ORAL
Labeler
Par Pharmaceutical Inc.
Application
ANDA040461
Marketing category
ANDA
Marketing start
2004-02-11
Marketing end
0000-00-00
Substance
MERCAPTOPURINE
Active strength
50 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA],Nucleoside Metabolic Inhibitor [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct49884-922DDiscontinued by firm2026-08-03
excluded packagepackage49884-92249884-922-02DDiscontinued by firm2026-08-03
excluded packagepackage49884-92249884-922-04DDiscontinued by firm2026-08-03

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 46 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-922-04DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49884-922-02DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-922-04DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49884-922-02DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-922-04DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49884-922-02DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-922-04DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49884-922-02DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-922-04DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49884-922-02DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-922-04DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49884-922-02DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductIInactivated by FDA302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-922-04DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49884-922-02DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductIInactivated by FDAed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-922-04DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49884-922-02DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductIInactivated by FDA0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-922-04DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49884-922-02DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductIInactivated by FDAad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-922-04DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49884-922-02DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductIInactivated by FDA367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-922-04DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49884-922-02DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductIInactivated by FDA557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-922-04DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49884-922-02DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproductIInactivated by FDA8af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproductIInactivated by FDA834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproductIInactivated by FDA1332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductIInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproductIInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductIInactivated by FDAbd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproductIInactivated by FDA8dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductEExcluded after deficient or non-compliant submission was not corrected110d247fa046…a55b01930146…

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
A040461-001MERCAPTOPURINEMERCAPTOPURINE50MGTABLET / ORALAB2004-02-11

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A040461-001AB

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 UTC2026-02A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-1131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-116a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-1103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-112680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-115bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-1179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-111e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-118072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-115c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-115d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-114b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-1174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-1187673890dc5c…
2021-03-12 10:30 UTC2021-03A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-115aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-118869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-113f01610625f2…
2019-09-15 20:21 UTC2019-09A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11b00525d2431f…
2019-07-19 19:46 UTC2019-07A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-116a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-111c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-119b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-113f0d92c62455…
2023-05-13 08:27 UTC2023-05A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11053a50430f4f…
2023-01-26 05:58 UTC2023-01A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-113bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-113a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040461-001MERCAPTOPURINE50MGTABLET / ORALAB2004-02-11cb3db0bc1861…

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 UTC2026-02A040461-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A040461-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A040461-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A040461-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A040461-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A040461-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A040461-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A040461-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A040461-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A040461-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A040461-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A040461-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A040461-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A040461-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A040461-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A040461-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A040461-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A040461-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A040461-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A040461-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A040461-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03A040461-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A040461-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A040461-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A040461-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A040461-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A040461-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A040461-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A040461-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A040461-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A040461-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A040461-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A040461-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A040461-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A040461-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01A040461-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A040461-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A040461-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A040461-001AB1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A040461-001AB1cb3db0bc1861…

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49884-922-02EA - Each49884-92225e9a1a6-dad6-40be-8536-1f5ba3d47b0e12012-07-24
49884-922-04EA - Each49884-9223e82ae64-9285-40d0-849a-d98da87af15212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mercaptopurineACTIVE INGREDIENTE7WED276I5MERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
MERCAPTOPURINE ANHYDROUSACTIVE MOIETYPKK6MUZ20GMERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
lactoseINACTIVE INGREDIENTJ2B2A4N98GMERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
stearic acidINACTIVE INGREDIENT4ELV7Z65APMERCAPTOPURINE TABLET [PAR PHARMACEUTICAL INC.]6
mercaptopurineACTIVE INGREDIENTE7WED276I5MERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
MERCAPTOPURINE ANHYDROUSACTIVE MOIETYPKK6MUZ20GMERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UMERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
lactoseINACTIVE INGREDIENTJ2B2A4N98GMERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3
stearic acidINACTIVE INGREDIENT4ELV7Z65APMERCAPTOPURINE TABLET [PHYSICIANS TOTAL CARE, INC.]3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197931mercaptopurine 50 MG Oral TabletPSN1db50d07-0326-4fb9-aa51-0a2493914e853
197931mercaptopurine 50 MG Oral TabletSCD1db50d07-0326-4fb9-aa51-0a2493914e853