FDA.reportPublic FDA data

NDC 51079-620-01 - 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
51079-620
Requested NDC
51079-620-01
Package NDCs from labels
51079-620-01, 51079-620-06
Manufacturer
Mylan Institutional Inc.
Effective date
2020-11-24
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azathioprine - Mylan Institutional Inc.Mylan Institutional Inc.2020-11-24HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-620-01EA - Each51079-62019d90c9a-f007-492b-9cf3-93c432f90daa12012-07-24
51079-620-06EA - Each51079-62026d68d6f-d17e-426e-9a48-e202fd8d712d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
POVIDONESINACTIVE INGREDIENTFZ989GH94EAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAZATHIOPRINE TABLET [MYLAN INSTITUTIONAL INC.]3

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 · 25 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
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
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINEPD-Rx Pharmaceuticals, Inc.d288e484-32fc-4b46-b504-d75a0fac86632026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINEAvKAREd4c7d621-9642-4027-e053-2995a90a92202026-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
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
unii: MRK240IY2L
AzathioprineAZATHIOPRINEOceanside Pharmaceuticalsd72ede2c-1a9b-4717-80a7-b76a6a4999362025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AzasanAZATHIOPRINESalix Pharmaceuticals9050af7a-19c6-4670-937a-9445605de9952025-09-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINEAmerican Health Packaging040d010a-b1b2-4db7-905d-8aa7f1bab0cd2025-05-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINEAscend Laboratories, LLCbc6dc4bd-2121-4613-9d90-4a504010c98a2025-04-23Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINERising Pharma Holdings, Inc.2ffa2fce-895d-469e-8667-b078560aec5f2025-02-04Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA075568
unii: MRK240IY2L
AzathioprineAZATHIOPRINEGolden State Medical Supply, Inc.8429e025-b79d-dae7-e053-2a91aa0a7fe52025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINENuCare Pharmaceuticals, Inc.2b9f91b9-7959-65e7-e063-6294a90a36802025-01-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Lifesciences Limited89b272f0-ef5c-49e4-820f-fcd7ea8ef0662024-11-25Exact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Lifesciences Limitedd65bc662-2ae8-4ddb-acc8-f616e72e61402024-11-25Exact identifier
unii: MRK240IY2L
AzathioprineAZATHIOPRINEZydus Pharmaceuticals USA Inc.b1b0fa3e-11c3-46d0-9537-6b372c2a1b562024-08-02Boxed warning, Warnings, Adverse reactionsExact identifier
unii: MRK240IY2L

Reported adverse events (FAERS/openFDA)#

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