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#

Effective, Related label table
Effective	Related label
2024-01-30	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
2024-01-30	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
2023-11-02	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
2023-11-02	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
2023-07-28	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
2023-07-28	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 27 of 105 · 2,092 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	152790ba-aeda-4c2a-b725-7e040e832883	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 1.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5f5cd18a-04fa-4b53-b7e9-6b1e97acc61a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	54f7fe8d-aab4-4fab-b239-52c5e7ce7c0c	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c87e5201-f7fd-4fd9-adeb-d6af9be00db6	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0CR	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84cdaad2-5b7d-4841-bef6-ffad4fe6907a	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 00	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	b4caa2bc-8118-4137-8834-25800f8e5e01	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 0.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	c0fa32fe-faa7-4a47-906c-14db01e55d47	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 8N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	ff1a8b32-c01f-4910-9a7a-c74eb49c05a0	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	d3bd710b-7d1a-4f96-9fbc-a67c550d863b	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	3b6ea0ec-4636-43cf-a324-a82666108e95	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 7.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ac7fb96-a2f2-4086-82ad-c45d7a709091	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	84a5f7e1-1c04-43cd-8d3b-60c7e2418faf	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	28a61b11-5901-47ec-916c-e2ae4f79a11d	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5ddf8221-9bfc-4c52-9a51-a0d725b7a23e	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 6.5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	5937248a-b96e-490a-9f93-10e65969ac10	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	2cc7d9f6-f789-4f9b-91b7-73f9d0fee85c	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 5N	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	62136c4c-6f05-4de0-a71e-55aa53160685	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WP	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	a8037741-ec57-43e7-adb4-2a93941ee108	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4WO	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	6f872199-067e-40aa-bf34-549ecc33b1ac	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP
FOREVER Transfer-proof - 24h foundation High perfection Concentrated floral skincare with sunscreen Broad spectrum SPF 15 4W	OCTISALATE, TITANIUM DIOXIDE	Parfums Christian Dior	4f27a485-1e8b-4f34-99a8-0d0a3cf1b9db	2025-12-19	Warnings	Exact identifier unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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