FDA.reportPublic FDA data

NDC 69238-1076-01 - 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
69238-1076
Requested NDC
69238-1076-01
Package NDCs from labels
69238-1076-1, 69238-1076-01
Manufacturer
Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC
Effective date
2021-02-02
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Azathioprine Tablets, USP (50 mg) Rx onlyAmneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals of New York, LLC2021-02-02HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1076-1AZATHIOPRINE100 in 1 BOTTLETABLET1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1076AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS NY LLC]5Current NDC, Legacy NDC, 1 package rows20231115_c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69238-1076-1EA - Each69238-1076289e8000-643b-4036-b3cc-83c712a9c17812015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AZATHIOPRINEACTIVE INGREDIENTMRK240IY2LAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
AZATHIOPRINEACTIVE MOIETYMRK240IY2LAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30AZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
POVIDONESINACTIVE INGREDIENTFZ989GH94EAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APAZATHIOPRINE TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]2

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 5 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy Artifical Tears Lubricant Eye DropsPOLYVINYL ALCOHOL, POVIDONEProficient Rx LP73e12596-6dd5-4cd2-83ed-992e1211b4b82023-12-01WarningsExact identifier
unii: FZ989GH94E
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
unii: 4ELV7Z65AP
AZATHIOPRINEAZATHIOPRINEAmneal Pharmaceuticals NY LLCc49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c2021-02-02Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074069
ndc (package): 69238-1076-1
ndc (product): 69238-1076
ndc11 (package): 69238107601
rxcui: 197388
spl id: d4549001-c251-4461-b3ff-5d25e9243918
spl set id: c49b7cc5-0eed-43b7-b7ad-cbb1b6f0cd2c
unii: MRK240IY2L
AZATHIOPRINEAZATHIOPRINEAphena Pharma Solutions - Tennessee, LLC2f994aed-f8e7-4967-a167-b22b783b41922018-09-05Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074069
rxcui: 197388
unii: MRK240IY2L

Reported adverse events (FAERS/openFDA)#

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