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
Label	Manufacturer	Effective date	Type
Sirolimus	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	2026-03-26	HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
59762-1002-1	2024-01-30	C162847	48780-1	0191ceaa-68ba-198a-e063-dbdaa90aec3e	These 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
59762-1002-1	2023-11-02	C162847	48780-1	0191ceaa-68ba-198a-e063-dbdaa90aec3e	These 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
59762-1002-1	2023-07-28	C162847	48780-1	0191ceaa-68ba-198a-e063-dbdaa90aec3e	These 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 NDC	Product	Description	Form	Quantity	Strength	SPL version
59762-1002-1	Sirolimus	100 in 1 BOTTLE	TABLET, SUGAR COATED	100		22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
59762-1002	SIROLIMUS TABLET, SUGAR COATED [MYLAN PHARMACEUTICALS INC.]	20	Current NDC, Legacy NDC, 1 package rows	20250529_5908cd1a-fc5a-462f-99ed-1d8983e253c9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
59762-1002-1	EA - Each	59762-1002	685f402c-f876-4a21-9f7b-e1a9acddc785	1	2014-11-05

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SIROLIMUS	ACTIVE INGREDIENT	W36ZG6FT64	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
SIROLIMUS	ACTIVE MOIETY	W36ZG6FT64	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
CALCIUM SULFATE	INACTIVE INGREDIENT	WAT0DDB505	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
CARNAUBA WAX	INACTIVE INGREDIENT	R12CBM0EIZ	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
CELLULOSE, MICROCRYSTALLINE	INACTIVE INGREDIENT	OP1R32D61U	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
FERRIC OXIDE YELLOW	INACTIVE INGREDIENT	EX438O2MRT	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
GLYCERYL OLEATE	INACTIVE INGREDIENT	4PC054V79P	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
LACTOSE MONOHYDRATE	INACTIVE INGREDIENT	EWQ57Q8I5X	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
MAGNESIUM STEARATE	INACTIVE INGREDIENT	70097M6I30	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
POLOXAMER 188	INACTIVE INGREDIENT	LQA7B6G8JG	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
POLYETHYLENE GLYCOL 8000	INACTIVE INGREDIENT	Q662QK8M3B	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
POVIDONE K29/32	INACTIVE INGREDIENT	390RMW2PEQ	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
SUCROSE	INACTIVE INGREDIENT	C151H8M554	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	SIROLIMUS TABLET, SUGAR COATED [GREENSTONE LLC]	8
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	SIROLIMUS 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 16 of 107 · 2,121 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1d6f10b7-60b9-47f6-9dba-1dd0a7cf6f5d	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	1aae19da-1e73-41ed-91dc-0746ad311b87	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	22d4452d-3798-48c6-a7a4-4af0f99b4ebd	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d6800bb7-16ef-48f6-a09a-0422e64ad8bd	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 6W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	fb9cfd4f-a558-4df2-bbbf-b814ae19a135	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b9ddcda6-3d87-4197-a2c2-5b30016d32eb	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 7W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	25abef37-1726-491f-8a11-ac1a96378ed1	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 8N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b0e315b3-a322-4607-b212-bcadd5aa99bc	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 9N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cc0f19fc-7b6f-4454-9a77-dc11f0fd1251	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 10N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c361a514-5fc9-42a7-b1fc-28e4a11ad733	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00 Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	db38ced5-dfbe-4b7e-b4ae-3065df1898b0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 00,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4ead1ce8-f31d-4676-8619-8d49dd62db2e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	827caf09-222e-487a-941c-44eb5c13d5d6	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0,5N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	f3c378e1-853b-463e-9fc3-6a54ef861044	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c3a479c4-807e-4c52-a27f-eea8705b9c1e	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 0W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	cb63faaa-82d8-469a-a9a1-88b09e02cc35	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1,5W Warm	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c20b0b8b-366a-47ff-84b6-264fa8ed6de0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1C Cool	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31d89246-418d-4ed4-8e32-7aa2422073a9	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1CR Cool Fosy	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	31b74e11-c5e5-4086-baa5-e7a39dc556a0	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP
Dior Forever Skin Glow Flawless Radiant Skin True Foundation SPF 25 1N Neutral	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	29ec217b-7726-4590-8a0d-e4b08217e222	2026-01-16	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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