Azathioprine

Product NDC
51407-182
11-digit product format
514070182
Labeler code
51407
Product ID
51407-182_2bb2bd7b-18fd-1821-e063-6294a90a5c0e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA075252
Marketing category
ANDA
Marketing start
1999-06-07
Substance
AZATHIOPRINE
Active strength
50 mg/1
Pharmacologic classes
Nucleic Acid Synthesis Inhibitors [MoA], Nucleosides [CS], Purine Antimetabolite [EPC], Purines [CS]
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A075252-001AZASANAZATHIOPRINE50MGTABLET / ORALAB1999-06-07
A075252-002AZASANAZATHIOPRINE25MGTABLET / ORALAB2003-02-03
A075252-003AZASANAZATHIOPRINE75MGTABLET / ORALAB2003-02-03
A075252-004AZASANAZATHIOPRINE100MGTABLET / ORALAB2003-02-03

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 4 matching rows.

Application-product, TE code table
Application-productTE code
A075252-001AB
A075252-002AB
A075252-003AB
A075252-004AB

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 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A075252-001AZASAN50MGTABLET / ORALAB1999-06-07011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-002AZASAN25MGTABLET / ORALAB2003-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-003AZASAN75MGTABLET / ORALAB2003-02-03011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-004AZASAN100MGTABLET / ORALAB2003-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-001AZASAN50MGTABLET / ORALAB1999-06-0731067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-002AZASAN25MGTABLET / ORALAB2003-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-003AZASAN75MGTABLET / ORALAB2003-02-0331067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-004AZASAN100MGTABLET / ORALAB2003-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A075252-001AZASAN50MGTABLET / ORALAB1999-06-076a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-002AZASAN25MGTABLET / ORALAB2003-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-003AZASAN75MGTABLET / ORALAB2003-02-036a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-004AZASAN100MGTABLET / ORALAB2003-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-001AZASAN50MGTABLET / ORALAB1999-06-07fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-002AZASAN25MGTABLET / ORALAB2003-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-003AZASAN75MGTABLET / ORALAB2003-02-03fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-004AZASAN100MGTABLET / ORALAB2003-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-001AZASAN50MGTABLET / ORALAB1999-06-07b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-002AZASAN25MGTABLET / ORALAB2003-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-003AZASAN75MGTABLET / ORALAB2003-02-03b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-004AZASAN100MGTABLET / ORALAB2003-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-001AZASAN50MGTABLET / ORALAB1999-06-0703ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-002AZASAN25MGTABLET / ORALAB2003-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-003AZASAN75MGTABLET / ORALAB2003-02-0303ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-004AZASAN100MGTABLET / ORALAB2003-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-001AZASAN50MGTABLET / ORALAB1999-06-072680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-002AZASAN25MGTABLET / ORALAB2003-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-003AZASAN75MGTABLET / ORALAB2003-02-032680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-004AZASAN100MGTABLET / ORALAB2003-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-001AZASAN50MGTABLET / ORALAB1999-06-075bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-002AZASAN25MGTABLET / ORALAB2003-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-003AZASAN75MGTABLET / ORALAB2003-02-035bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-004AZASAN100MGTABLET / ORALAB2003-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-001AZASAN50MGTABLET / ORALAB1999-06-07d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-002AZASAN25MGTABLET / ORALAB2003-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-003AZASAN75MGTABLET / ORALAB2003-02-03d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-004AZASAN100MGTABLET / ORALAB2003-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075252-001AZASAN50MGTABLET / ORALAB1999-06-07d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-002AZASAN25MGTABLET / ORALAB2003-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-003AZASAN75MGTABLET / ORALAB2003-02-03d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-004AZASAN100MGTABLET / ORALAB2003-02-03d06236e962d9…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 5 · 164 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A075252-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-003AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A075252-004AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-003AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A075252-004AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A075252-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-003AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A075252-004AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-003AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A075252-004AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-003AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A075252-004AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-003AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A075252-004AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-003AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A075252-004AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-003AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A075252-004AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-003AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A075252-004AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A075252-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-003AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A075252-004AB1d06236e962d9…

Additional Listing Data#

Finished product
Yes
Brand name base
Azathioprine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AZATHIOPRINE50 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MRK240IY2LInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
197388Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8429e025-b79d-dae7-e053-2a91aa0a7fe5Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f4d1a46-20f1-4d12-8172-10a68a29bd37Product name120200714
6675d21e-6399-b5b7-7c97-62806f9c86aaProduct name220200714
e3ccdd15-9c9c-362f-f2a0-79d5e384527fProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-182-01Azathioprine100 in 1 BOTTLETABLET1009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-182-01EA - Each51407-18238d89e2b-16f6-4f04-9192-62b3f9f6295d12019-05-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-182AZATHIOPRINE TABLET [GOLDEN STATE MEDICAL SUPPLY, INC.]9Current NDC, Legacy NDC, 1 package rows20250119_8429e025-b79d-dae7-e053-2a91aa0a7fe5.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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzathioprineAZATHIOPRINEOceanside Pharmaceuticalsd72ede2c-1a9b-4717-80a7-b76a6a4999362025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075252
application number: ANDA075252
AzasanAZATHIOPRINESalix Pharmaceuticals9050af7a-19c6-4670-937a-9445605de9952025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075252
application number: ANDA075252
AzathioprineAZATHIOPRINEGolden State Medical Supply, Inc.8429e025-b79d-dae7-e053-2a91aa0a7fe52025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075252
application number: ANDA075252
ndc (product): 51407-182
AzathioprineAZATHIOPRINEGlenmark Pharmaceuticals, Incceab8e8b-d022-4d0c-a552-cc57824462482024-11-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 075252
application number: ANDA075252

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197388azaTHIOprine 50 MG Oral TabletPSN8429e025-b79d-dae7-e053-2a91aa0a7fe59
197388azathioprine 50 MG Oral TabletSCD8429e025-b79d-dae7-e053-2a91aa0a7fe59
197388azaTHIOprine 50 MG Oral TabletPSN91461b02-75d1-4f44-9a8a-a8b8080e61651
197388azathioprine 50 MG Oral TabletSCD91461b02-75d1-4f44-9a8a-a8b8080e61651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51407-182-0151407018201100 TABLET in 1 BOTTLE (51407-182-01) 100 tablet2018-12-070000-00-00NoNoCurrent