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 4 of 121 · 2,416 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MENS SPF50 ALL IN ONE SUNSCREENMENS SPF50 ALL IN ONE SUNSCREENLance (Guangzhou) Biological Technology Co., Ltd.57074480-77fd-cc06-e063-6294a90a28d42026-07-20WarningsExact identifier
unii: 15FIX9V2JP
SirolimusSIROLIMUSREMEDYREPACK INC.fc81cb86-61e1-4622-b2ce-cde263143aa02026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 349208
unii: W36ZG6FT64
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC571083ce-cd35-a638-e063-6394a90ae4c72026-07-20WarningsExact identifier
unii: 1K09F3G675
Yves Saint Laurent All Hours Foundation Sunscreen Broad Spectrum SPF 30 Luminous Matte FoundationOCTINOXATE AND TITANIUM DIOXIDEL'Oreal USA Products Inc5711364c-f9b4-bfa6-e063-6294a90ace4a2026-07-20WarningsExact identifier
unii: 15FIX9V2JP
CalamineFERRIC OXIDE REDBetter Living Brands, LLCc7ef0ef3-6861-4b94-af4b-371fee8c1f3d2026-07-16Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30DERMIO DERMATOLOGY LLC562f5b0d-6a10-305d-e063-6394a90a59802026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30Suzanne's Skin2soul LLC562fbaa6-f93a-5ec4-e063-6294a90a96342026-07-08WarningsExact identifier
unii: 15FIX9V2JP
Aussie Betta Tallow Sunscreen SPF50 SPF50TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREENAUSSIE BETTA HEALTHY CARE PTY LTD56007d82-ff5b-6c26-e063-6294a90a09b62026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: 3NXW29V3WO
EELHOE Body Coverage PerfectorTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.5610c3b7-456b-3bc1-e063-6394a90a3fa82026-07-07WarningsExact identifier
unii: 15FIX9V2JP
Premier Tinted Mineral SunscreenBROAD SPECTRUM SPF30Emerald Aesthetics LLC55f88dd1-346c-22a5-e063-6294a90a711f2026-07-06WarningsExact identifier
unii: 15FIX9V2JP
clear laxPOLYETHYLENE GLYCOL 3350HyVee Inc5bcf01d8-ddf3-4e64-8d3f-3526a51a58592026-07-02WarningsExact identifier
unii: G2M7P15E5P
OHUI Ultimate Cover CC Cushion Compact 02 Natural BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d307471c-6cc6-ce48-e053-2995a90a3e022026-07-02WarningsExact identifier
unii: 15FIX9V2JP
CLEARLAXPOLYETHYLENE GLYCOL 3350Safewaya70f41d0-0fad-4d15-8844-d60eabeb67322026-07-02WarningsExact identifier
unii: G2M7P15E5P
Evereden Fluid Silk Mineral Sunscreen PRO SPF50TITANIUM DIOXIDE, ZINC OXIDEEden Brands Inc.2cb7773f-9a05-ad02-e063-6294a90af0242026-07-01WarningsExact identifier
unii: 15FIX9V2JP
OHUI Ultimate Cover CC Cushion Compact 01 Light BeigeTITANIUM DIOXIDELG H&H Co., Ltd.d2f9c54b-ac4e-5141-e053-2a95a90aa2b82026-06-30WarningsExact identifier
unii: 15FIX9V2JP
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYTarget Corporation36602b7a-99c0-f6a4-e063-6294a90a87582026-06-29WarningsExact identifier
unii: 1K09F3G675
TOCOBO Blur Finish Sun Cushion Cotton BlueHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE, ZINC OXIDEPICTON Co., Ltd.4d6ddee3-9a76-6c9c-e063-6394a90a15292026-06-29WarningsExact identifier
unii: 15FIX9V2JP
Earth Baby Broad Spectrum SPF 30SUNSCREENEarth Baby, Inc.42556876-74ea-38e6-e054-00144ff8d46c2026-06-28WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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