MERCAPTOPURINE

Product NDC
62484-1020
11-digit product format
624841020
Labeler code
62484
Product ID
62484-1020_036bd090-ea77-44bb-993b-da0e376517ac
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
MERCAPTOPURINE
Dosage form
SUSPENSION
Route
ORAL
Labeler
Nova Laboratories, Ltd
Application
NDA205919
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2025-09-08
Substance
MERCAPTOPURINE
Active strength
20 mg/mL
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleoside Metabolic Inhibitor [EPC]
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
N205919-001PURIXANMERCAPTOPURINE20MG/MLSUSPENSION / ORALABRLD, RS2014-04-28

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N205919-001AB

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 UTC2026-02N205919-001PURIXAN20MG/MLSUSPENSION / ORALABRLD, RS2014-04-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALABRLD, RS2014-04-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N205919-001PURIXAN20MG/MLSUSPENSION / ORALABRLD, RS2014-04-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205919-001PURIXAN20MG/MLSUSPENSION / ORALABRLD, RS2014-04-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N205919-001PURIXAN20MG/MLSUSPENSION / ORALRLD, RS2014-04-28cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02N205919-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N205919-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N205919-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N205919-001AB1fd3edfee7708…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N205919-001AB1a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N205919-001ODE-652021-04-2874a2ff9319b5…
2021-12-28 21:50 UTC2021-12N205919-001ODE-652021-04-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N205919-001ODE-652021-04-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N205919-001ODE-652021-04-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N205919-001ODE-652021-04-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N205919-001ODE-652021-04-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N205919-001ODE-652021-04-283f01610625f2…
2019-09-15 20:21 UTC2019-09N205919-001ODE-652021-04-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N205919-001ODE-652021-04-28ea99ee380514…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MERCAPTOPURINE20 mg/mL

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
1536484Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9c6fc66b-522f-499d-961a-cde6ca0ec2e5Available 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
62484-1020-3MERCAPTOPURINE100 mL in 1 BOTTLESUSPENSION1005
62484-1020-4MERCAPTOPURINE1 in 1 CARTONSUSPENSION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62484-1020-3ML - Milliliter62484-1020dd0f8efa-9c8b-49eb-9b93-92955dcc4e5c12026-01-08
62484-1020-4ML - Milliliter62484-102086967a7d-8a03-48ec-8537-519afe094ded12026-01-08

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
PURIXANPURIXANNova Laboratories, Ltd9fd27952-7787-47d9-b6cf-7af2dc38217b2026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 205919
application number: NDA205919
MERCAPTOPURINEMERCAPTOPURINENova Laboratories, Ltd9c6fc66b-522f-499d-961a-cde6ca0ec2e52026-07-20Warnings, Adverse reactionsExact identifier
application applno (NDA): 205919
application number: NDA205919
ndc (product): 62484-1020

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1536484mercaptopurine 20 MG in 1 mL Oral SuspensionPSN9c6fc66b-522f-499d-961a-cde6ca0ec2e55
1536484mercaptopurine 20 MG/ML Oral SuspensionSCD9c6fc66b-522f-499d-961a-cde6ca0ec2e55
1536484mercaptopurine 100 MG per 5 ML Oral SuspensionSY9c6fc66b-522f-499d-961a-cde6ca0ec2e55
1536484mercaptopurine 20 MG per 1 ML Oral SuspensionSY9c6fc66b-522f-499d-961a-cde6ca0ec2e55
1536484mercaptopurine 2000 MG per 100 ML Oral SuspensionSY9c6fc66b-522f-499d-961a-cde6ca0ec2e55

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62484-1020-362484102003100 mL in 1 BOTTLE100 mlHistorical
62484-1020-4624841020041 BOTTLE in 1 CARTON (62484-1020-4) / 100 mL in 1 BOTTLE (62484-1020-3) 1 bottle2025-09-08NoNoCurrent