Azathioprine

Product NDC
0615-7568
11-digit product format
006157568
Labeler code
0615
Product ID
0615-7568_011f3ad5-2b31-4560-9aad-ae158eff396d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Azathioprine
Dosage form
TABLET
Route
ORAL
Labeler
NCS HealthCare of KY, Inc dba Vangard Labs
Application
ANDA074069
Marketing category
ANDA
Marketing start
1996-02-16
Marketing end
0000-00-00
Substance
AZATHIOPRINE
Active strength
50 mg/1
Pharmacologic classes
Nucleoside Analog [EXT],Purine Antimetabolite [EPC],Purines [CS],Nucleic Acid Synthesis Inhibitors [MoA]
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 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0615-7568DDiscontinued by firm2026-08-03
excluded packagepackage0615-75680615-7568-39DDiscontinued 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 · 30 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 packagepackage0615-7568-39DDiscontinued 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 packagepackage0615-7568-39DDiscontinued 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 packagepackage0615-7568-39DDiscontinued 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 packagepackage0615-7568-39DDiscontinued 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 packagepackage0615-7568-39DDiscontinued 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 packagepackage0615-7568-39DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0615-7568-39DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0615-7568-39DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0615-7568-39DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0615-7568-39DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0615-7568-39DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0615-7568-39DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproductIInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage0615-7568-39IInactivated by FDAe2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproductIInactivated by FDA9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage0615-7568-39IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0615-7568-39IInactivated by FDA110d247fa046…a55b01930146…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A074069-001AZATHIOPRINEAZATHIOPRINE50MGTABLET / ORALAB1996-02-16
A074069-002AZATHIOPRINEAZATHIOPRINE75MGTABLET / ORALAB2021-11-02
A074069-003AZATHIOPRINEAZATHIOPRINE100MGTABLET / ORALAB2021-11-02

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 3 matching rows.

Application-product, TE code table
Application-productTE code
A074069-001AB
A074069-002AB
A074069-003AB

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 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-0231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-026a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-0203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-022680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-025bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16d06236e962d9…
2024-10-29 15:01 UTC2024-10A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02d06236e962d9…
2024-10-29 15:01 UTC2024-10A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-0279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-02301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-002AZATHIOPRINE75MGTABLET / ORALAB2021-11-021e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-003AZATHIOPRINE100MGTABLET / ORALAB2021-11-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074069-001AZATHIOPRINE50MGTABLET / ORALAB1996-02-168072bd15b7f6…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 107 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A074069-001AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074069-002AB1011fe1cb6892…
2026-02-19 14:30 UTC2026-02A074069-003AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-001AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-002AB131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A074069-003AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A074069-001AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074069-002AB16a471c1ec25d…
2025-08-23 18:47 UTC2025-08A074069-003AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-001AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-002AB1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A074069-003AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-001AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-002AB1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A074069-003AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-001AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-002AB103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A074069-003AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-001AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-002AB12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A074069-003AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-001AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-002AB15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A074069-003AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-001AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-002AB1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A074069-003AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A074069-001AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074069-002AB1d06236e962d9…
2024-10-29 15:01 UTC2024-10A074069-003AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-001AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-002AB179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A074069-003AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-001AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-002AB1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A074069-003AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-001AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-002AB11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A074069-003AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A074069-001AB18072bd15b7f6…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0615-7568-392021-03-05C16284748780-1956f9ecf-d059-621f-e053-dbdaa90a74adAZATHIOPRINE Tablets USP, 50 mg
0615-7568-392019-10-21C16284748780-1956f9ecf-d059-621f-e053-dbdaa90a74adAZATHIOPRINE Tablets USP, 50 mg

DailyMed Socrata Ingredients#

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AZATHIOPRINEAZATHIOPRINEPD-Rx Pharmaceuticals, Inc.d288e484-32fc-4b46-b504-d75a0fac86632026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069
AZATHIOPRINEAZATHIOPRINEAvKAREf93d9408-7b3f-b423-e053-6294a90a31ec2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069
AZATHIOPRINEAZATHIOPRINEAvKAREd4c7d621-9642-4027-e053-2995a90a92202026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069
AZATHIOPRINEAZATHIOPRINEAmneal Pharmaceuticals NY LLC59f3219f-898f-4d05-a430-c2b3f5255af12025-12-11Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069
AZATHIOPRINEAZATHIOPRINEAmneal Pharmaceuticals NY LLCc49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c2021-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069
AZATHIOPRINEAZATHIOPRINEAphena Pharma Solutions - Tennessee, LLC2f994aed-f8e7-4967-a167-b22b783b41922018-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 074069
application number: ANDA074069