Home NDC 65219-200 Temsirolimus
Product NDC 65219-200
11-digit product format 652190200
Labeler code 65219
Product ID 65219-200_2b33d5f1-198e-41ef-ac78-ccfd27fc137a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Temsirolimus
Dosage form KIT
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA207383
Marketing category ANDA
Marketing start 2020-11-20
NDC exclude flag No
Listing certified through 2026-12-31
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 A207383-001 TEMSIROLIMUS TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A207383-001 AP
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 2026-02-19 14:30 UTC 2026-02 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 b00525d2431f…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A207383-001 TEMSIROLIMUS 25MG/ML (25MG/ML) SOLUTION / INTRAVENOUS AP 2019-08-16 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Temsirolimus
Listing expiration 2026-12-31 Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 722289 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 65219-200-05 Temsirolimus 1 in 1 KIT KIT 1 2 65219-205-05 Temsirolimus 1 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION, CONCENTRATE 1 mL 25 mg in 1mL 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-200 TEMSIROLIMUS KIT [FRESENIUS KABI USA, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20201120_1c207bed-10e3-46f0-ad2c-69d5e5c97736.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 · 3 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 65219-200-05 65219020005 1 KIT in 1 KIT (65219-200-05) * 1 mL in 1 VIAL, SINGLE-DOSE (65219-205-05) * 1.8 mL in 1 VIAL, SINGLE-DOSE (65219-202-05) 1 kit 2020-11-20 0000-00-00 No No Current 65219-205-05 65219020505 1 mL in 1 VIAL, SINGLE-DOSE 1 ml Historical