Home NDC 65219-447 Etomidate
Product NDC 65219-447
11-digit product format 652190447
Labeler code 65219
Product ID 65219-447_30488a7e-ea9e-4a27-95a9-a07149c50282
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Etomidate
Dosage form INJECTION, SOLUTION
Route INTRAVENOUS
Labeler Fresenius Kabi USA, LLC
Application ANDA215028
Marketing category ANDA
Marketing start 2021-08-01
Substance ETOMIDATE
Active strength 2 mg/mL
Pharmacologic classes General Anesthesia [PE], General Anesthetic [EPC]
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 A215028-001 ETOMIDATE ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215028-001 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 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 5aa47cf7b7d7…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215028-001 ETOMIDATE 2MG/ML INJECTABLE / INJECTION AP 2020-12-18 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Etomidate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ETOMIDATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination Z22628B598 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1654006 Internal RxNorm lookup 1654008 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 65219-447-02 Etomidate 20 mL in 1 VIAL, SINGLE-DOSE INJECTION, SOLUTION 20 5 65219-447-20 Etomidate 10 in 1 CARTON INJECTION, SOLUTION 10 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65219-447 ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC
] 5 Current NDC, Legacy NDC, 2 package rows 20230805_d07efb9e-5264-461d-96d8-e11fa71c5751.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 · 4 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 65219-447-02 65219044702 20 mL in 1 VIAL, SINGLE-DOSE 20 ml Historical 65219-447-20 65219044720 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-447-20) / 20 mL in 1 VIAL, SINGLE-DOSE (65219-447-02) 2021-08-01 0000-00-00 No No Current