FDA.reportPublic FDA data

NDC 70518-3544-1 - 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
70518-3544
Requested NDC
70518-3544-1
Package NDCs from labels
70518-3544-1, 70518-3544-0
Manufacturer
REMEDYREPACK INC.
Effective date
2026-04-13
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azathioprine Tablets, USP Scored Tablets PRODUCT INFORMATION Rx onlyREMEDYREPACK INC.2026-04-13HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70518-3544-0Azathioprine100 in 1 BOXTABLET1004
70518-3544-1Azathioprine1 in 1 POUCHTABLET14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3544AZATHIOPRINE TABLET [REMEDYREPACK INC.]2Current NDC, Legacy NDC, 2 package rows20240116_f251f372-c881-483e-8035-c6a8a6bfb4e8.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
ndc (package): 70518-3544-1
ndc (package): 70518-3544-0
ndc (product): 70518-3544
ndc11 (package): 70518354401
rxcui: 197388
spl id: 4f58b212-db57-4132-e063-6394a90a1cdf
spl set id: f251f372-c881-483e-8035-c6a8a6bfb4e8
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 (product): 67877-493
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.