Home NDC 66689-347 Sirolimus
Product NDC 66689-347
11-digit product format 666890347
Labeler code 66689
Product ID 66689-347_909758a8-92f7-443a-bfe1-3f2f6cb98eb0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Sirolimus
Dosage form SOLUTION
Route ORAL
Labeler VistaPharm, LLC
Application ANDA211040
Marketing category ANDA
Marketing start 2019-01-28
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 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.
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
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination W36ZG6FT64 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 314230 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 66689-347-02 Sirolimus 1 in 1 CARTON SOLUTION 1 11 66689-347-02 Sirolimus 1 in 1 KIT SOLUTION 1 11
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 66689-347 SIROLIMUS SOLUTION [VISTAPHARM, LLC] 10 Current NDC, Legacy NDC, 2 package rows 20240209_19880f51-badb-4846-a02a-592a210690ab.zip
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 66689-347-02 66689034702 1 CARTON in 1 KIT (66689-347-02) / 1 BOTTLE in 1 CARTON / 60 mL in 1 BOTTLE 1 carton 2019-01-28 0000-00-00 No No Current