FDA.reportPublic FDA data

NDC 67877-492-33 - Azathioprine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
67877-492
Requested NDC
67877-492-33
Package NDCs from labels
67877-492-01, 67877-492-05, 67877-492-10, 67877-492-14, 67877-492-33, 67877-492-38
Manufacturer
Ascend Laboratories, LLC | Alkem Laboratories Limited
Effective date
2025-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azathioprine - Ascend Laboratories, LLC | Alkem Laboratories LimitedAscend Laboratories, LLC | Alkem Laboratories Limited2025-04-23Human Prescription Drug Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-492-01Azathioprine100 in 1 BOTTLETABLET1009
67877-492-05Azathioprine500 in 1 BOTTLETABLET5009
67877-492-10Azathioprine1000 in 1 BOTTLETABLET10009
67877-492-14Azathioprine14 in 1 BLISTER PACKTABLET149
67877-492-14Azathioprine1 in 1 CARTONTABLET19
67877-492-33Azathioprine10 in 1 BLISTER PACKTABLET109
67877-492-38Azathioprine10 in 1 CARTONTABLET109

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-492AZATHIOPRINE TABLET [ASCEND LABORATORIES, LLC]9Current NDC, Legacy NDC, 7 package rows20250425_bc6dc4bd-2121-4613-9d90-4a504010c98a.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 2 · 23 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AzathioprineAZATHIOPRINENuCare Pharmaceuticals,Inc.5116b22b-1460-5535-e063-6394a90acbe52026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208687
rxcui: 197388
unii: MRK240IY2L
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
AzathioprineAZATHIOPRINEREMEDYREPACK INC.f251f372-c881-483e-8035-c6a8a6bfb4e82026-04-13Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208687
rxcui: 197388
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINEPD-Rx Pharmaceuticals, Inc.d288e484-32fc-4b46-b504-d75a0fac86632026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
AZATHIOPRINEAZATHIOPRINEAvKAREf93d9408-7b3f-b423-e053-6294a90a31ec2026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 359228
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINEAvKAREd4c7d621-9642-4027-e053-2995a90a92202026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
IMURANAZATHIOPRINESebela Pharmaceuticals Inc.606101a0-6244-7eff-e053-2a91aa0acadd2025-11-08Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINEOceanside Pharmaceuticalsd72ede2c-1a9b-4717-80a7-b76a6a4999362025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 359228
rxcui: 359229
unii: MRK240IY2L
AzasanAZATHIOPRINESalix Pharmaceuticals9050af7a-19c6-4670-937a-9445605de9952025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 359228
rxcui: 359229
unii: MRK240IY2L
AzathioprineAZATHIOPRINEAmerican Health Packaging040d010a-b1b2-4db7-905d-8aa7f1bab0cd2025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINEAscend Laboratories, LLCbc6dc4bd-2121-4613-9d90-4a504010c98a2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA208687
ndc (package): 67877-492-01
ndc (package): 67877-495-01
ndc (package): 67877-494-01
ndc (package): 67877-495-05
ndc (package): 67877-494-33
ndc (package): 67877-495-33
ndc (package): 67877-493-38
ndc (package): 67877-494-05
ndc (package): 67877-492-38
ndc (package): 67877-494-10
ndc (package): 67877-495-38
ndc (package): 67877-492-14
ndc (package): 67877-492-33
ndc (package): 67877-493-10
ndc (package): 67877-492-10
ndc (package): 67877-492-05
ndc (package): 67877-494-38
ndc (package): 67877-493-01
ndc (package): 67877-495-10
ndc (package): 67877-493-05
ndc (package): 67877-493-33
ndc (product): 67877-493
ndc (product): 67877-495
ndc (product): 67877-494
ndc (product): 67877-492
ndc11 (package): 67877049233
rxcui: 359228
rxcui: 197388
rxcui: 199310
rxcui: 359229
spl id: 7fdec2f6-c3b5-483f-8bfc-0afb292781da
spl set id: bc6dc4bd-2121-4613-9d90-4a504010c98a
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINERising Pharma Holdings, Inc.2ffa2fce-895d-469e-8667-b078560aec5f2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINEGolden State Medical Supply, Inc.8429e025-b79d-dae7-e053-2a91aa0a7fe52025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINENuCare Pharmaceuticals, Inc.2b9f91b9-7959-65e7-e063-6294a90a36802025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Lifesciences Limited89b272f0-ef5c-49e4-820f-fcd7ea8ef0662024-11-25Exact identifier
rxcui: 359228
rxcui: 199310
rxcui: 359229
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Lifesciences Limitedd65bc662-2ae8-4ddb-acc8-f616e72e61402024-11-25Exact identifier
rxcui: 197388
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Pharmaceuticals USA Inc.b1b0fa3e-11c3-46d0-9537-6b372c2a1b562024-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 359228
rxcui: 197388
rxcui: 199310
rxcui: 359229
unii: MRK240IY2L

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.