Home NDC 59762-1002 Sirolimus
Product NDC 59762-1002
11-digit product format 597621002
Labeler code 59762
Product ID 59762-1002_8f2761f9-9bc3-47c3-8093-6375a39d1034
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIROLIMUS
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Mylan Pharmaceuticals Inc.
Application NDA021110
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2014-10-27
Substance SIROLIMUS
Active strength 1 mg/1
Pharmacologic classes Decreased Immunologic Activity [PE], Kinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA], mTOR Inhibitor Immunosuppressant [EPC], mTOR Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 4 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N021110-001 RAPAMUNE SIROLIMUS 1MG TABLET / ORAL AB RLD 2000-08-25 N021110-002 RAPAMUNE SIROLIMUS 2MG TABLET / ORAL AB RLD, RS 2002-08-22 N021110-003 RAPAMUNE SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 N021110-004 RAPAMUNE SIROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-01-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 3 matching rows.
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 5 · 164 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-003 RAPAMUNE 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 d06236e962d9…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 123 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Additional Listing Data#
Finished product Yes
Brand name base Sirolimus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIROLIMUS 1 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W36ZG6FT64 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 3 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 349208 Internal RxNorm lookup 360110 Internal RxNorm lookup 905158 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# 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 Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded 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
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
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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59762-1002-1 59762100201 100 TABLET, SUGAR COATED in 1 BOTTLE (59762-1002-1) 2014-10-27 0000-00-00 No No Current