NDC 68084-915-95 - 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
68084-915
Requested NDC
68084-915-95
Package NDCs from labels
68084-915-95, 68084-915-25
Manufacturer
American Health Packaging
Effective date
2025-08-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sirolimus - American Health PackagingAmerican Health Packaging2025-08-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68084-915-25Sirolimus30 in 1 BOX, UNIT-DOSETABLET309
68084-915-95Sirolimus1 in 1 BLISTER PACKTABLET19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68084-915SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]8Current NDC, Legacy NDC, 2 package rows20240117_5df60452-2b16-4ce9-8c29-48798a59d718.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68084-915-25EA - Each68084-9156480bcdf-267f-43e9-9fa8-8ca8ed699dc712015-12-02
68084-915-95EA - Each68084-9157859dbda-bace-45c9-8935-788911f1e75712015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
sirolimusACTIVE INGREDIENTW36ZG6FT64SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
sirolimusACTIVE MOIETYW36ZG6FT64SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
ammoniaINACTIVE INGREDIENT5138Q19F1XSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
carnauba waxINACTIVE INGREDIENTR12CBM0EIZSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61USIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
DIACETYLATED MONOGLYCERIDESINACTIVE INGREDIENT5Z17386USFSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
ethylcellulosesINACTIVE INGREDIENT7Z8S9VYZ4BSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOASIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
hypromellose 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
magnesium stearateINACTIVE INGREDIENT70097M6I30SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
mannitolINACTIVE INGREDIENT3OWL53L36ASIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
poloxamer 188INACTIVE INGREDIENTLQA7B6G8JGSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
POVIDONESINACTIVE INGREDIENTFZ989GH94ESIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
shellacINACTIVE INGREDIENT46N107B71OSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
sucroseINACTIVE INGREDIENTC151H8M554SIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPSIROLIMUS TABLET [AMERICAN HEALTH PACKAGING]1

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 118 · 2,349 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OTTFFSS SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4e76504b-82da-e7a4-e063-6294a90a4f812026-07-30WarningsExact identifier
unii: 5138Q19F1X
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
unii: 6DC9Q167V3
REINREUDE SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4c29c7f0-0d34-40bd-e063-6294a90a6ca72026-07-24WarningsExact identifier
unii: 5138Q19F1X
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
PNV-OmegaASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CORBONATE, FERROUS FUMARATE, POTASSIUM IODIDE, MAGNESIUM, DOCONEXENT, ICOSAPENTAcella Pharmaceuticals, LLC735c5531-137f-4cee-8c68-ae121045a8ff2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: H4N855PNZ1
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
SERYNTH SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD4a4be985-7de7-4eba-e063-6394a90ac84e2026-07-21WarningsExact identifier
unii: 5138Q19F1X
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
Lepnuns SMELLING SALTSAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD497f5bd0-b913-706b-e063-6394a90abf302026-07-20WarningsExact identifier
unii: 5138Q19F1X
WXMX Smelling SaltsAMMONIA 15% SMELLING SALTSJiangxi Yudexi Pharmaceutical Co., LTD49927820-1862-4792-e063-6294a90acf9e2026-07-20WarningsExact identifier
unii: 5138Q19F1X
SirolimusSIROLIMUSREMEDYREPACK INC.fc81cb86-61e1-4622-b2ce-cde263143aa02026-07-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA201578
rxcui: 349208
unii: W36ZG6FT64
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
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
unii: 6DC9Q167V3
Bombee Honey Daily Glow Shield SunscreenHOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDEABT ASIA Inc.56112dff-b091-7a56-e063-6294a90a77d32026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB3 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a233350-729a-1e0c-e063-6394a90ad48c2026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB9 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f72b-4c33-a100-e063-6294a90ac6322026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB10 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a241d80-b9d2-ea93-e063-6294a90ab3662026-07-08WarningsExact identifier
unii: 15FIX9V2JP
SKIN-INFUSED FOUNDATION SPF 25- shade BB8 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.4a23f728-a824-48a6-e063-6394a90acae72026-07-08WarningsExact identifier
unii: 15FIX9V2JP