FDA.reportPublic FDA data

NDC 59762-1002-01 - 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
59762-1002
Requested NDC
59762-1002-01
Package NDCs from labels
59762-1002-1, 59762-1002-01
Manufacturer
Mylan Pharmaceuticals Inc. | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company
Effective date
2026-03-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
SirolimusMylan Pharmaceuticals Inc. | Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc. | Wyeth Pharmaceutical Division of Wyeth Holdings LLC | Pfizer Manufacturing Deutschland GmbH | Pfizer Ireland Pharmaceuticals Unlimited Company2026-03-26HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2024-01-30These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
2024-01-30These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
2023-11-02These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
2023-11-02These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
2023-07-28These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999
2023-07-28These highlights do not include all the information needed to use SIROLIMUS safely and effectively. See full prescribing information for SIROLIMUS. SIROLIMUS tablets, for oral use Initial U.S. Approval: 1999

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-1002-1Sirolimus100 in 1 BOTTLETABLET, SUGAR COATED10022

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-1002SIROLIMUS TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.]20Current NDC, Legacy NDC, 1 package rows20250529_5908cd1a-fc5a-462f-99ed-1d8983e253c9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-1002-1EA - Each59762-1002685f402c-f876-4a21-9f7b-e1a9acddc78512014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SIROLIMUSACTIVE INGREDIENTW36ZG6FT64SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
SIROLIMUSACTIVE MOIETYW36ZG6FT64SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CALCIUM SULFATEINACTIVE INGREDIENTWAT0DDB505SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
GLYCERYL OLEATEINACTIVE INGREDIENT4PC054V79PSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POLOXAMER 188INACTIVE INGREDIENTLQA7B6G8JGSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POLYETHYLENE GLYCOL 8000INACTIVE INGREDIENTQ662QK8M3BSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
POVIDONE K29/32INACTIVE INGREDIENT390RMW2PEQSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
SUCROSEINACTIVE INGREDIENTC151H8M554SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
TALCINACTIVE INGREDIENT7SEV7J4R1USIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]8

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 40 of 105 · 2,092 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Matte FinishTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3761d74c-0137-0c75-e063-6394a90a3c7d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sun Plus Sun Lip ShieldTITANIUM DIOXIDE, ZINC OXIDECLEAN BEAUTY BY ANAK LLC3763a79a-e881-cade-e063-6394a90a49de2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC374e53c6-307f-f8e5-e063-6394a90a07ef2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Minerals 1point8 ozTITANIUM DIOXIDE, ZINC OXIDESPECKTRA6 LLC373e29f1-d665-a3c4-e063-6294a90a403e2025-12-11Exact identifier
unii: 15FIX9V2JP
Defend Tinted Mineral SPF 40TITANIUM DIOXIDE, ZINC OXIDESMOOTH ESTHETICS LLC36eb9fc0-25d7-cfb4-e063-6394a90a2e222025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen SPF40TITANIUM DIOXIDE, ZINC OXIDESIMPLICITY SKIN, SPA & BOUTIQUE, LLC36ebdb85-ce8a-d7e0-e063-6394a90a22612025-12-11Exact identifier
unii: 15FIX9V2JP
Mineral Lip ProtectionTITANIUM DIOXIDE, ZINC OXIDECOLETTE TOMASI LLC3727b29f-fe51-0b15-e063-6394a90a780b2025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c291a-7839-8486-e063-6294a90a5af32025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention 2 Acne Safe Facial Mineral Sunscreen Non TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373c0ab0-8828-542b-e063-6394a90a86332025-12-11Exact identifier
unii: 15FIX9V2JP
Prevention Acne Safe Facial Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDENY BEAUTY PALACE LLC373d4fad-141c-0904-e063-6394a90a97592025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37617bd5-c275-aeee-e063-6394a90a214d2025-12-11Exact identifier
unii: 15FIX9V2JP
Mattify Total Protection SunscreenTITANIUM DIOXIDE, ZINC OXIDECLEAN SLATE SKIN & BODY, INC.37641f8b-0133-8bfc-e063-6294a90aac5c2025-12-11Exact identifier
unii: 15FIX9V2JP
Essential Mineral Sun ProtectionTITANIUM DIOXIDE, ZINC OXIDEFern Burg34a360b2-6798-c7e8-e063-6294a90a5cbb2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b72d14-b69b-e9dd-e063-6394a90a748e2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESCIENCE CEUTICALS, LLC369b20e2-2cad-e047-e063-6294a90a1bba2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Mineral Matte CE SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b60880-5fe1-b78f-e063-6294a90a748d2025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b51190-6a6d-c5e0-e063-6394a90ae8752025-12-11Exact identifier
unii: 15FIX9V2JP
Sheer Tinted Sunscreen StickTITANIUM DIOXIDE, ZINC OXIDEThe Maui Medical Group, Inc34b6e8d0-6235-dac2-e063-6394a90afefd2025-12-11Exact identifier
unii: 15FIX9V2JP
Tinted Sunscreen Face PrimerTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY374f6b79-2ac4-61cf-e063-6394a90a699b2025-12-11Exact identifier
unii: 15FIX9V2JP
Daily Sun DefenseTITANIUM DIOXIDE, ZINC OXIDELIV BODY AND BEAUTY LLC3750c2fd-c5cc-fd00-e063-6394a90aeb892025-12-11Exact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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