FDA.reportPublic FDA data

NDC 65841-771-30 - sirolimus

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
65841-771
Requested NDC
65841-771-30
Package NDCs from labels
65841-771-01, 65841-771-06, 65841-771-16, 65841-771-05, 65841-771-10, 65841-771-30, 65841-771-77
Manufacturer
Zydus Lifesciences Limited
Effective date
2023-09-27
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
sirolimus - Zydus Lifesciences LimitedZydus Lifesciences Limited2023-09-27HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65841-771-01sirolimus100 in 1 BOTTLETABLET, FILM COATED10011
65841-771-05sirolimus500 in 1 BOTTLETABLET, FILM COATED50011
65841-771-06sirolimus30 in 1 BOTTLETABLET, FILM COATED3011
65841-771-10sirolimus1000 in 1 BOTTLETABLET, FILM COATED100011
65841-771-16sirolimus90 in 1 BOTTLETABLET, FILM COATED9011
65841-771-30sirolimus10 in 1 BLISTER PACKTABLET, FILM COATED1011
65841-771-77sirolimus10 in 1 CARTONTABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-771SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, Legacy NDC, 7 package rows20230928_82562b68-224d-482a-b399-a89b81d5eb31.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIROLIMUSACTIVE INGREDIENTW36ZG6FT64SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
SIROLIMUSACTIVE MOIETYW36ZG6FT64SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
CROSPOVIDONEINACTIVE INGREDIENT68401960MKSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
GLYCERYL MONOOLEATEINACTIVE INGREDIENT4PC054V79PSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ASIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
POVIDONEINACTIVE INGREDIENTFZ989GH94ESIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
SUCROSEINACTIVE INGREDIENTC151H8M554SIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
TALCINACTIVE INGREDIENT7SEV7J4R1USIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIROLIMUS TABLET, FILM COATED [CADILA HEALTHCARE LIMITED]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 121 · 2,416 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
leader clearlaxPOLYETHYLENE GLYCOL 3350Cardinal Health 110, LLC. dba Leader812c59b0-e7ce-4c7a-91ed-e74b7b1b84be2026-09-22WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350L.N.K. International, Inc.bbc11078-73f7-4d27-b0d3-4d4ae5dae2402026-09-10WarningsExact identifier
unii: G2M7P15E5P
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
Leader Artificial Tears 15 mLPOLYVINYL ALCOHOL, POVIDONECardinal Health8cccc589-3a8e-baad-e053-2a95a90ab8c72026-09-09WarningsExact identifier
unii: FZ989GH94E
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC7ed915ec-7e99-4e0e-aca0-20718987a88c2026-09-08WarningsExact identifier
unii: G2M7P15E5P
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacyfc3b6006-a75a-41b3-9f0b-a3152df1363f2026-09-04WarningsExact identifier
unii: G2M7P15E5P
basic care clearlaxPOLYETHYLENE GLYCOL 3350Amazon.com Services LLC1ccb8604-34f6-4e1e-beed-eb81d6aa7aef2026-09-03WarningsExact identifier
unii: G2M7P15E5P
purelaxPOLYETHYLENE GLYCOL 3350CVS Pharmacy006a9eca-400f-47f5-bee5-facf7034043e2026-09-02WarningsExact identifier
unii: G2M7P15E5P
KrogerPOLYETHYLENE GLYCOL 3350KROGER COMPANYc56271ff-703a-40c4-840f-1962798c9e422026-09-02WarningsExact identifier
unii: G2M7P15E5P
gentle laxPOLYETHYLENE GLYCOL 3350Kroger Company0d820dcc-440a-4036-86e9-fdb30cac95732026-09-01WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350Amazon.com Services LLCbd33463b-eb1a-41ed-92d1-f50d0923eb3b2026-08-31WarningsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Cardinal Health 107, LLC4d524ace-9de5-4f62-9263-7cd88a36b67c2026-08-28WarningsExact identifier
unii: G2M7P15E5P
PEG3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticals161629f6-6193-4712-bba7-7d5b174a93382026-08-28WarningsExact identifier
unii: G2M7P15E5P
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
Mix-In Laxative PacketsPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc0347c934-1e85-4f8d-8d35-bb07f16810ad2026-08-27WarningsExact identifier
unii: G2M7P15E5P
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675

Reported adverse events (FAERS/openFDA)#

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