FDA.reportPublic FDA data

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 115 · 2,297 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
FRESHKOTE PRESERVATIVE FREE LUBRICANT EYE DROPSPOVIDONE, POLYVINYL ALCOHOL SOLUTIONHarrow Eye, LLC049e9cc9-0663-53bc-e063-6294a90a2c4f2026-09-04WarningsExact identifier
unii: FZ989GH94E
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIAShenzhen Finona Information Technology Co., Ltd3874ec89-0f1d-87b9-e063-6394a90a300a2026-08-24WarningsExact identifier
unii: 5138Q19F1X
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Rohto Optic GlowNAPHAZOLINE HYDROCHLORIDE, POVIDONE, PROPYLENE GLYCOLThe Mentholatum Companydf9c5f7c-96e6-4b2b-b8cb-21a6a3342dff2026-08-20WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSHodayfa Abu Alkian524e002c-f509-9395-e063-6394a90acd9e2026-08-20WarningsExact identifier
unii: 5138Q19F1X
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
Smelling SaltsAMMONIA INHALANT, SMELLING SALTSShenzhen Leadtop E-commerce Co.,Ltd.558e8629-6a8d-198d-e063-6294a90ac5fc2026-08-19WarningsExact identifier
unii: 5138Q19F1X
Rohto Preservative Free Dry AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Companyf4b1974c-2412-45f6-b79d-88b8a0bcb6082026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Rohto Dry-AidPOVIDONE, PROPYLENE GLYCOLThe Mentholatum Company8ea5c6c9-48f4-406a-a2cb-9280c546d87d2026-08-18WarningsExact identifier
unii: 6DC9Q167V3
unii: FZ989GH94E
Smelling SaltAMMONIAShenzhen Jufeng Qisheng Technology Co., Ltd.44e1b2c1-f524-782c-e063-6394a90ad1e42026-08-18WarningsExact identifier
unii: 5138Q19F1X
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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