Home NDC 70954-075 Sirolimus
Product NDC 70954-075
11-digit product format 709540075
Labeler code 70954
Product ID 70954-075_207aa9ba-2d4d-4e70-a4d8-688065ef92a9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form SOLUTION
Route ORAL
Labeler Novitium Pharma LLC
Application ANDA211040
Marketing category ANDA
Marketing start 2019-05-21
Marketing end 0000-00-00
Substance SIROLIMUS
Active strength 1 mg/mL
Pharmacologic classes Decreased Immunologic Activity [PE],mTOR Inhibitor Immunosuppressant [EPC],mTOR Inhibitors [MoA],Kinase Inhibitor [EPC],Protein Kinase Inhibitors [MoA]
NDC exclude flag No
Listing certified through 2020-12-31
Current FDA listing Historical FDA.report record Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211040-001 SIROLIMUS SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211040-001 AA
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 2 · 41 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 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211040-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-01-28 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 observed states.
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 VistaPharm, LLC 19880f51-badb-4846-a02a-592a210690ab 2024-04-30 Boxed warning, Warnings, Adverse reactions Exact identifier application applno (ANDA): 211040 application number: ANDA211040