Home NDC 13668-658-87 Sirolimus
Product NDC 13668-658
Requested package NDC 13668-658-87
11-digit product format 136680658
Labeler code 13668
Product ID 13668-658_d4b251f6-5378-2fc1-e053-2a95a90a73bf
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form SOLUTION
Route ORAL
Labeler Torrent pharmaceuticals limited
Application ANDA215016
Marketing category ANDA
Marketing start 2021-12-27
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 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 · 12 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Snapshot, Source SHA-256 table Captured / source date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…9c80585c8c6e…
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
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 A215016-001 SIROLIMUS SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27
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.
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 2026-08-18 06:07:40 2026-07 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2021-12-27 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2021-12-27 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2021-12-27 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL AA 2021-12-27 bb7c543d1eb4…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215016-001 SIROLIMUS 1MG/ML SOLUTION / ORAL 2021-12-27 a50c72e98297…
Observed Orange Book normalized TE history# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 13668-658-87 13668065887 1 CARTON in 1 KIT (13668-658-87) > 1 BOTTLE, GLASS in 1 CARTON > 60 mL in 1 BOTTLE, GLASS (13668-658-13) 1 carton 2021-12-27 0000-00-00 No No Current