Home DailyMed 9ee8fb06-ce81-487a-84a2-5a11282fdbfc National Council for Prescription Drug Programs indexing - billing unit Drug label information. FDA.report displays public Structured Product Labeling data from DailyMed and legacy FDA.report DailyMed cache rows. This page is not medical advice, prescribing advice, or a substitute for the official label reviewed by a qualified healthcare professional. Labeling can change; when a current hydrated DailyMed SPL record is available, FDA.report shows that newer record before legacy cached files.
Manufacturer National Council for Prescription Drug Programs
Effective date 2012-07-24
Label type Indexing - Billing Unit
Version 1
Source full-release
Hydrated at 2026-06-05 02:20:54 Orange Book application contexts# All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book application contexts page 1 of 1 · 1 matching rows.
Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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RS 2002-08-22 N021110-003 RAPAMUNE SIROLIMUS 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** TABLET / ORAL RLD 2004-02-23 N021110-004 RAPAMUNE SIROLIMUS 0.5MG TABLET / ORAL AB RLD 2010-01-25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 · 172 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 2026-09-14 22:38:34 2026-08 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 84e616aacf4f…2026-09-14 22:38:34 2026-08 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 84e616aacf4f…2026-09-14 22:38:34 2026-08 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 84e616aacf4f…2026-08-18 06:07:40 2026-07 N021110-001 RAPAMUNE 1MG TABLET / ORAL AB RLD 2000-08-25 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021110-002 RAPAMUNE 2MG TABLET / ORAL AB RLD, RS 2002-08-22 caaa826d4ba7…2026-08-18 06:07:40 2026-07 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 caaa826d4ba7…2026-08-18 06:07:40 2026-07 N021110-004 RAPAMUNE 0.5MG TABLET / ORAL AB RLD 2010-01-25 caaa826d4ba7…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…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 4 · 129 observed states.
Observed Orange Book exclusivity history# Exclusivity history page 1 of 2 · 72 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.