Home NDC 70518-4449 sirolimus
Product NDC 70518-4449
11-digit product format 705184449
Labeler code 70518
Product ID 70518-4449_5b35bc0d-6935-d3dc-e063-6394a90af540
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name sirolimus
Dosage form TABLET, FILM COATED
Route ORAL
Labeler REMEDYREPACK INC.
Application ANDA208691
Marketing category ANDA
Marketing start 2025-08-19
Substance SIROLIMUS
Active strength .5 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 43 .
Orange Book products# Current product rows page 1 of 1 · 3 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A208691-001 SIROLIMUS SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 A208691-002 SIROLIMUS SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 A208691-003 SIROLIMUS SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16
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 3 · 114 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 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 84e616aacf4f…2026-09-14 22:38:34 2026-08 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 84e616aacf4f…2026-08-18 06:07:40 2026-07 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-08-18 06:07:40 2026-07 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-10-29 15:01 UTC 2024-10 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-002 SIROLIMUS 1MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A208691-003 SIROLIMUS 2MG TABLET / ORAL AB 2020-10-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A208691-001 SIROLIMUS 0.5MG TABLET / ORAL AB 2020-10-16 301d65b070ca…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 114 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base sirolimus
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength SIROLIMUS .5 mg/1
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70518-4449-0 sirolimus 100 in 1 BOX TABLET, FILM COATED 100 1 70518-4449-1 sirolimus 1 in 1 POUCH TABLET, FILM COATED 1 1
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 · 2 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 70518-4449-0 70518444900 100 POUCH in 1 BOX (70518-4449-0) / 1 TABLET, FILM COATED in 1 POUCH (70518-4449-1) 100 pouch 2025-08-19 No No Current 70518-4449-1 70518444901 1 in 1 POUCH Historical