Home NDC 0008-1042 Rapamune
Product NDC 0008-1042
11-digit product format 000081042
Labeler code 0008
Product ID 0008-1042_88b60b59-91f1-445d-a08f-a0a55c69d2d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIROLIMUS
Dosage form TABLET, SUGAR COATED
Route ORAL
Labeler Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.
Application NDA021110
Marketing category NDA
Marketing start 2001-07-01
Marketing end 0000-00-00
Substance SIROLIMUS
Active strength 2 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 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 0008-1042 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 0008-1042 0008-1042-05 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
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RS 2002-08-22 N021110-003 RAPAMUNE SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 N021110-004 RAPAMUNE SIROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-01-25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.
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded SIROLIMUS ACTIVE INGREDIENT W36ZG6FT64 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 SIROLIMUS ACTIVE MOIETY W36ZG6FT64 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 .ALPHA.-TOCOPHEROL ACETATE INACTIVE INGREDIENT 9E8X80D2L0 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 CALCIUM SULFATE INACTIVE INGREDIENT WAT0DDB505 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 CARNAUBA WAX INACTIVE INGREDIENT R12CBM0EIZ RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 FERRIC OXIDE YELLOW INACTIVE INGREDIENT EX438O2MRT RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 GLYCERYL OLEATE INACTIVE INGREDIENT 4PC054V79P RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 LACTOSE MONOHYDRATE INACTIVE INGREDIENT EWQ57Q8I5X RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 POLYETHYLENE GLYCOL 8000 INACTIVE INGREDIENT Q662QK8M3B RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 POVIDONE K29/32 INACTIVE INGREDIENT 390RMW2PEQ RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 SUCROSE INACTIVE INGREDIENT C151H8M554 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 TALC INACTIVE INGREDIENT 7SEV7J4R1U RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS INC., A SUBSIDIARY OF PFIZER INC.] 47
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0008-1042 RAPAMUNE (SIROLIMUS) SOLUTION RAPAMUNE (SIROLIMUS) TABLET, SUGAR COATED [WYETH PHARMACEUTICALS LLC, A SUBSIDIARY OF PFIZER INC.] 73 Legacy NDC 20250110_3275b824-3f82-4151-2ab2-0036a9ba0acc.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.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sirolimus SIROLIMUS Mylan Pharmaceuticals Inc. 5908cd1a-fc5a-462f-99ed-1d8983e253c9 2026-03-26 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (NDA): 021110 application number: NDA021110
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 0008-1042-05 00008104205 100 TABLET, SUGAR COATED in 1 BOTTLE (0008-1042-05) 2001-07-01 0000-00-00 No No Current