NDC 68382-352-30 - 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
68382-352
Requested NDC
68382-352-30
Package NDCs from labels
68382-352-01, 68382-352-30, 68382-352-77
Manufacturer
Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited
Effective date
2023-07-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
sirolimus - Zydus Pharmaceuticals USA Inc. | Zydus Lifesciences LimitedZydus Pharmaceuticals USA Inc. | Zydus Lifesciences Limited2023-07-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68382-352-01sirolimus100 in 1 BOTTLETABLET, FILM COATED10016
68382-352-30sirolimus10 in 1 BLISTER PACKTABLET, FILM COATED1016
68382-352-77sirolimus10 in 1 CARTONTABLET, FILM COATED1016

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68382-352SIROLIMUS TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]16Current NDC, 3 package rows20230720_ec473170-47f1-4a5c-b4d9-ac36406ed241.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68382-352-01EA - Each68382-35269a2230a-9f37-4716-9353-d3929c93be7f12023-04-07

DailyMed Socrata Ingredients#

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

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 121 · 2,418 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sun Does Matter Daily Face SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDESundoesmatter Company Inc.553687d8-d4e1-8361-e063-6294a90a24fe2026-06-27WarningsExact identifier
unii: 15FIX9V2JP
Ivory Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f25ba-61d5-6a94-e063-6394a90a46e92026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Simply Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f4799-9122-8db5-e063-6394a90a51322026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Vanilla Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f6d2c-9b8c-aa52-e063-6294a90a787e2026-06-26WarningsExact identifier
unii: 15FIX9V2JP
Coral Isle SPF 50 Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDERocky Mountain5515f562-62d9-c6ee-e063-6294a90a9ea62026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Delicate Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551928b4-74bb-3f6c-e063-6294a90a6b832026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc5519290c-b040-6a37-e063-6394a90a8a1d2026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Soft Bisque Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551ab7d1-dd2f-c6d8-e063-6394a90aff652026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Alabaster Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc551b8c21-3afc-c804-e063-6294a90a51562026-06-25WarningsExact identifier
unii: 15FIX9V2JP
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
SET 4TE HOMOADEPS SUILLUS, BRYONIA (ALBA), CALCAREA PHOSPHORICA, CHOLINUM, DNA, DOPAMINE (HYDROCHLORIDE), FERRUM PHOSPHORICUM, FOLIC ACID, INSULINUM (HUMAN), LEPTIN, MAGNESIA MURIATICA, L-METHIONINE, METHYLCOBALAMIN, PROTEUS (VULGARIS), RHUS TOX, RIBOFLAVINUM, RUTA GRAVEOLENS, SACCHARUM OFFICINALE, THIOSINAMINUM, ZINCUM METALLICUMDeseret Biologicals, Inc.e7b8d75b-f2bc-4013-91e7-bf5bbec11a902026-06-25WarningsExact identifier
unii: C151H8M554
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fd8a72-0527-df0c-e063-6294a90abe752026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fddca1-b40c-7af0-e063-6294a90a410e2026-06-24Exact identifier
unii: 2968PHW8QP
Leukotrap WB SystemCPDA-1 BLOOD BAG COLLECTION SYSTEMGVS TM INC54fdf83e-f641-1f69-e063-6394a90ab7502026-06-24Exact identifier
unii: 2968PHW8QP
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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