Etomidate

Product NDC: 65219-445
11-digit product format: 652190445
Labeler code: 65219
Product ID: 65219-445_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	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#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A215028-001	AP	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A215028-001	AP	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A215028-001	AP	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A215028-001	AP	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A215028-001	AP	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A215028-001	AP	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A215028-001	AP	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A215028-001	AP	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A215028-001	AP	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A215028-001	AP	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A215028-001	AP	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A215028-001	AP	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A215028-001	AP	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A215028-001	AP	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A215028-001	AP	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A215028-001	AP	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A215028-001	AP	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A215028-001	AP	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A215028-001	AP	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A215028-001	AP	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A215028-001	AP	1	`5aa47cf7b7d7…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A215028-001	AP	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A215028-001	AP	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A215028-001	AP	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A215028-001	AP	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A215028-001	AP	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A215028-001	AP	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A215028-001	AP	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A215028-001	AP	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A215028-001	AP	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A215028-001	AP	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A215028-001	AP	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A215028-001	AP	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A215028-001	AP	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A215028-001	AP	1	`a50c72e98297…`

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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
d07efb9e-5264-461d-96d8-e11fa71c5751	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fe0c5d6c-1467-3506-5566-aee700997367	Product name	5	20210610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
65219-445-01	Etomidate	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	5
65219-445-10	Etomidate	10 in 1 CARTON	INJECTION, SOLUTION	10	5
65219-445-12	Etomidate	10 mL in 1 VIAL, SINGLE-DOSE	INJECTION, SOLUTION	10	1
65219-445-22	Etomidate	10 in 1 CARTON	INJECTION, SOLUTION	10	1

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
65219-445-01	ML - Milliliter	65219-445	a6589a31-4bee-4ff6-b261-ab1b1bbe1b7d	1	2021-09-07
65219-445-10	ML - Milliliter	65219-445	27fe7089-bc43-4d07-adf1-c7c58a8bc6f5	1	2021-09-07
65219-445-12	ML - Milliliter	65219-445	1df2c557-9485-4e04-a1ea-e9b2151ec8b7	1	2024-01-04
65219-445-22	ML - Milliliter	65219-445	6a7eab3d-78a5-475d-ba01-3f1a25d55d40	1	2024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65219-445	ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	5	Current NDC, Legacy NDC, 2 package rows	20230805_d07efb9e-5264-461d-96d8-e11fa71c5751.zip
65219-445	ETOMIDATE (ETOMIDATE) INJECTION, SOLUTION [FRESENIUS KABI USA, LLC ]	1	Current NDC, Legacy NDC, 2 package rows	20231001_f38fad46-f2dd-4692-a2a9-a13d0a717bf8.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Etomidate	ETOMIDATE	Caplin Steriles Limited	9c2d0014-9e74-40b2-b452-255016c81cc1	2026-02-05	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028
Etomidate	ETOMIDATE	Armas Pharmaceuticals Inc.	75467058-da52-48fa-8d4e-e1025ec7d461	2024-01-22	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	2023-08-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028 ndc (product): 65219-445
Etomidate	ETOMIDATE	Fresenius Kabi USA, LLC	d07efb9e-5264-461d-96d8-e11fa71c5751	2023-07-27	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 215028 application number: ANDA215028 ndc (product): 65219-445

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
Z22628B598	ETOMIDATE	33125-97-2	ETOMIDATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1654006	etomidate 20 MG in 10 ML Injection	PSN	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654008	etomidate 40 MG in 20 ML Injection	PSN	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654006	10 ML etomidate 2 MG/ML Injection	SCD	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654008	20 ML etomidate 2 MG/ML Injection	SCD	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654006	etomidate 20 MG per 10 ML Injection	SY	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654008	etomidate 40 MG per 20 ML Injection	SY	d07efb9e-5264-461d-96d8-e11fa71c5751	5
1654006	etomidate 20 MG in 10 ML Injection	PSN	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	1
1654006	10 ML etomidate 2 MG/ML Injection	SCD	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	1
1654006	etomidate 20 MG per 10 ML Injection	SY	f38fad46-f2dd-4692-a2a9-a13d0a717bf8	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
65219-445-01	65219044501	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
65219-445-10	65219044510	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-10) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-01)		2021-08-01	0000-00-00	No	No	Current
65219-445-12	65219044512	10 mL in 1 VIAL, SINGLE-DOSE	10 ml					Historical
65219-445-22	65219044522	10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-22) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-12)		2023-10-01		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etomidate - Fresenius Kabi USA, LLC \| Caplin Steriles Limited	Fresenius Kabi USA, LLC \| Caplin Steriles Limited	2023-08-10	HUMAN PRESCRIPTION DRUG LABEL	1
Etomidate - Fresenius Kabi USA, LLC \| Caplin Steriles Limited	Fresenius Kabi USA, LLC \| Caplin Steriles Limited	2023-07-27	HUMAN PRESCRIPTION DRUG LABEL	5