Home NDC 60505-6197 Sirolimus
Product NDC 60505-6197
11-digit product format 605056197
Labeler code 60505
Product ID 60505-6197_cbf93a5b-f0a1-f8b1-6373-19cca65aa9f3
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name SIROLIMUS
Dosage form SOLUTION
Route ORAL
Labeler Apotex Corp
Application ANDA211406
Marketing category ANDA
Marketing start 2020-05-20
Substance SIROLIMUS
Active strength 1 mg/mL
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 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A211406-001 SIROLIMUS SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A211406-001 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 2026-09-14 22:38:34 2026-08 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 84e616aacf4f…2026-08-18 06:07:40 2026-07 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 3f01610625f2…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A211406-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2019-10-22 cb3db0bc1861…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 41 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 1 mg/mL
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 60505-6197-2 Sirolimus 60 mL in 1 BOTTLE, GLASS SOLUTION 60 6 60505-6197-2 Sirolimus 1 in 1 CARTON SOLUTION 1 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 60505-6197 SIROLIMUS SOLUTION [APOTEX CORP] 5 Current NDC, Legacy NDC, 2 package rows 20240809_9f64692d-2a18-ffcb-c572-0f218a71ca67.zip
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 60505-6197-2 60505619702 1 BOTTLE, GLASS in 1 CARTON (60505-6197-2) / 60 mL in 1 BOTTLE, GLASS 2020-05-20 2025-03-31 No No Current