etomidate

Product NDC: 25021-674
Requested package NDC: 25021-674-10
11-digit product format: 250210674
Labeler code: 25021
Product ID: 25021-674_53cc21c1-422a-4eee-b2d8-828148c576db
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: etomidate
Dosage form: INJECTION, SOLUTION
Route: INTRAVENOUS
Labeler: Sagent Pharmaceuticals
Application: ANDA215028
Marketing category: ANDA
Marketing start: 2012-08-10
Marketing end: 0000-00-00
Substance: ETOMIDATE
Active strength: 2 mg/mL
Pharmacologic classes: General Anesthesia [PE], General Anesthetic [EPC]
NDC exclude flag: No
Listing certified through: 2023-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	25021-674	25021-674-10	D	Discontinued by firm		2026-08-03

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 · 11 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…`

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…`

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
25021-674-10	ML - Milliliter	25021-674	4418f12f-f4a1-44e3-ab39-b8d8f42563e0	1	2013-02-13
25021-674-20	ML - Milliliter	25021-674	ab144138-9fef-4ed4-9f35-f5eab3818dff	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
etomidate	ACTIVE INGREDIENT	Z22628B598	ETOMIDATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
etomidate	ACTIVE MOIETY	Z22628B598	ETOMIDATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	ETOMIDATE INJECTION, SOLUTION [SAGENT PHARMACEUTICALS]	2

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
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

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
25021-674-10	25021067410	10 VIAL in 1 CARTON (25021-674-10) > 10 mL in 1 VIAL	10 vial	2012-08-10	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Etomidate Injection, USP (For Intravenous Use)	Sagent Pharmaceuticals	2021-03-30	HUMAN PRESCRIPTION DRUG LABEL	6