FDA.reportPublic FDA data

NDC 65841-772-30 - 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
65841-772
Requested NDC
65841-772-30
Package NDCs from labels
65841-772-01, 65841-772-30, 65841-772-77
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
65841-772-01sirolimus100 in 1 BOTTLETABLET, FILM COATED10011
65841-772-30sirolimus10 in 1 BLISTER PACKTABLET, FILM COATED1011
65841-772-77sirolimus10 in 1 CARTONTABLET, FILM COATED1011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65841-772SIROLIMUS TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]11Current NDC, 3 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 3 of 121 · 2,416 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Journee Firm Riche Broad Spectrum Sunscreen SPF 30TITANIUM DIOXIDE AND ZINC OXIDEMerz North America, Inc.d4d4bfcf-3674-4847-8ad8-1716a8e821ae2026-08-10WarningsExact identifier
unii: 15FIX9V2JP
VEIRFOO Brightening Hydrating Antiwrinkle SunscreenTITANIUM DIOXIDE, OCTINOXATELCM TECHNOLOGY Co., Ltd4cbbf8aa-8910-b7e7-e063-6294a90a4f072026-08-07WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDThe Kroger Co.9ddcd6ba-1aed-48f8-a91a-54bd6f0d93082026-08-06Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
ROROBELL WAWA Kids Tooth Natural Green Grape FlavorHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL586b499d-23bf-0116-e063-6394a90aa7d42026-08-06WarningsExact identifier
unii: 9E8X80D2L0
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350The Fresh Test, LLCcb8e182f-c23f-4f8d-9c09-24e19b2e914e2026-08-05WarningsExact identifier
unii: G2M7P15E5P
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: 9E8X80D2L0
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
ROROBELL WAWA Gum Care ToothHYDRATED SILICA, SODIUM FLUORIDE, TOCOPHERYL ACETATEROROBELL582204ef-b784-0d95-e063-6394a90a38d22026-08-03WarningsExact identifier
unii: 9E8X80D2L0
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
Continuous Correction CreamTITANIUM DIOXIDEBaxter of California, LLC1cbcc648-f2e1-af60-e063-6294a90ad4bb2026-07-31WarningsExact identifier
unii: 15FIX9V2JP
Cover CremeTITANIUM DIOXIDEBaxter of California31f5e8c4-523f-4596-e063-6294a90a6a122026-07-31WarningsExact identifier
unii: 15FIX9V2JP
IDkit HP ONECITRIC ACID ANHYDROUS AND 13C UREAMeridian Bioscience Israel Ltd8baab7a7-5d20-46ad-9c4a-762992ef6b512026-07-28Warnings, Adverse reactionsExact identifier
unii: 2968PHW8QP
Polyethylene Glycol 3350INSTALAX POLYETHYLENE GLYCOL 3350Sun Pharmaceutical Industries, Inc.40bd1be7-de67-8dff-e063-6294a90aca952026-07-24WarningsExact identifier
unii: G2M7P15E5P
ESIKA COLORFIX POLVOS 32H POLVO COMPACTO FACIAL DE ALTA COBERTURA FPS 15 110-COCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEBEL STAR S.A.575fb2c3-e332-8a3b-e063-6394a90a9fd92026-07-24WarningsExact identifier
unii: 15FIX9V2JP
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEA-S Medication Solutions19daf830-7270-4661-81b1-ded38f867f282026-07-24Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
True Coast SPF 50 Mineral SunscreenZINC OXIDE 18%, TITANIUM DIOXIDE 6%Foshan Sugar Max Cosmetics CO.,Ltd5379466d-8d14-5fc2-e063-6394a90abd7e2026-07-22WarningsExact identifier
unii: 15FIX9V2JP
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
unii: 1K09F3G675
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
unii: FZ989GH94E
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDESICOS ET CIE571f23e9-1126-e32d-e063-6294a90a99512026-07-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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