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 1 of 5 · 84 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: FZ989GH94E
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: FZ989GH94E
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
unii: FZ989GH94E
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
unii: FZ989GH94E
RippleGLYCERIN, POVIDONECorneaCare Inc3b5ba197-d501-681e-e063-6294a90aefb52026-05-24WarningsExact identifier
unii: FZ989GH94E
AzathioprineAZATHIOPRINENuCare Pharmaceuticals,Inc.5116b22b-1460-5535-e063-6394a90acbe52026-05-05Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 197388
unii: MRK240IY2L
iVIZIA Lubricant Eye GelPOVIDONEThea Pharma Inc.1f06ca1a-5270-9a82-e063-6294a90aed642026-04-29WarningsExact identifier
unii: FZ989GH94E
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLPreferred PHarmaceuticals Inc.011473a8-26d5-4661-b3c0-745f9b6aa1d82026-04-29WarningsExact identifier
unii: FZ989GH94E
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
rxcui: 197388
unii: MRK240IY2L
FreshKote Preservative Free Lubricant Eye DropsPOVIDONE, POLYVINYL ALCOHOLEyevance Pharmaceuticalsf51c50c3-43ae-4169-9d2b-22b239461dd12026-04-08WarningsExact identifier
unii: FZ989GH94E
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
unii: FZ989GH94E
AZATHIOPRINEAZATHIOPRINEPD-Rx Pharmaceuticals, Inc.d288e484-32fc-4b46-b504-d75a0fac86632026-02-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA074069
rxcui: 197388
unii: MRK240IY2L
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
unii: FZ989GH94E
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
unii: FZ989GH94E

Reported adverse events (FAERS/openFDA)#

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