Etomidate

Product NDC
72266-146
11-digit product format
722660146
Labeler code
72266
Product ID
72266-146_2b365133-b609-3285-e063-6394a90a69a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Etomidate Injection
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
Fosun Pharma USA Inc
Application
ANDA209058
Marketing category
ANDA
Marketing start
2019-09-03
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A209058-001ETOMIDATEETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A209058-001AP

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-183f01610625f2…
2019-09-15 20:21 UTC2019-09A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209058-001ETOMIDATE2MG/MLINJECTABLE / INJECTIONAP2017-04-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A209058-001AP1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A209058-001AP131067a03dcf5…
2025-08-23 18:47 UTC2025-08A209058-001AP16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A209058-001AP1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A209058-001AP1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A209058-001AP103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A209058-001AP12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A209058-001AP15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A209058-001AP1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A209058-001AP1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A209058-001AP179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A209058-001AP1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A209058-001AP11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A209058-001AP18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A209058-001AP15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A209058-001AP15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A209058-001AP14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A209058-001AP174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A209058-001AP1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A209058-001AP1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A209058-001AP187673890dc5c…
2021-03-12 10:30 UTC2021-03A209058-001AP15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A209058-001AP18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A209058-001AP1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A209058-001AP13f01610625f2…
2019-09-15 20:21 UTC2019-09A209058-001AP1b00525d2431f…
2019-07-19 19:46 UTC2019-07A209058-001AP1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A209058-001AP16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A209058-001AP11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A209058-001AP1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A209058-001AP1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A209058-001AP19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A209058-001AP1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A209058-001AP13f0d92c62455…
2023-05-13 08:27 UTC2023-05A209058-001AP1053a50430f4f…
2023-01-26 05:58 UTC2023-01A209058-001AP13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A209058-001AP13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A209058-001AP1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A209058-001AP1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A209058-001AP1cb3db0bc1861…

Additional Listing Data#

Finished product
Yes
Brand name base
Etomidate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ETOMIDATE2 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
Z22628B598Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1654006Internal RxNorm lookup
1654008Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
8b6c54d8-3f3f-4290-841c-976bea01086fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fe0c5d6c-1467-3506-5566-aee700997367Product name520210610

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72266-146-01Etomidate10 mL in 1 VIALSOLUTION103
72266-146-10Etomidate10 in 1 CARTONSOLUTION103

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72266-146-01ML - Milliliter72266-1465b711ee8-e3e1-48c5-b5cc-77f7ed1fdc5412019-10-07
72266-146-10ML - Milliliter72266-146c96ddb7f-169b-40f2-a6aa-24baea1a0b7f12019-10-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72266-146ETOMIDATE (ETOMIDATE INJECTION) SOLUTION [FOSUN PHARMA USA INC]3Current NDC, Legacy NDC, 2 package rows20250110_8b6c54d8-3f3f-4290-841c-976bea01086f.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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
EtomidateETOMIDATE INJECTIONFosun Pharma USA Inc8b6c54d8-3f3f-4290-841c-976bea01086f2019-07-28Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209058
application number: ANDA209058
ndc (product): 72266-146
EtomidateETOMIDATE INJECTIONGland Pharma Limited94cde4e7-3b46-419f-8dda-87675da8d89d2017-10-17Warnings, Adverse reactionsExact identifier
application applno (ANDA): 209058
application number: ANDA209058

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1654006etomidate 20 MG in 10 ML InjectionPSN8b6c54d8-3f3f-4290-841c-976bea01086f3
1654008etomidate 40 MG in 20 ML InjectionPSN8b6c54d8-3f3f-4290-841c-976bea01086f3
165400610 ML etomidate 2 MG/ML InjectionSCD8b6c54d8-3f3f-4290-841c-976bea01086f3
165400820 ML etomidate 2 MG/ML InjectionSCD8b6c54d8-3f3f-4290-841c-976bea01086f3
1654006etomidate 20 MG per 10 ML InjectionSY8b6c54d8-3f3f-4290-841c-976bea01086f3
1654008etomidate 40 MG per 20 ML InjectionSY8b6c54d8-3f3f-4290-841c-976bea01086f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72266-146-017226601460110 mL in 1 VIAL10 mlHistorical
72266-146-107226601461010 VIAL in 1 CARTON (72266-146-10) / 10 mL in 1 VIAL (72266-146-01) 10 vial2019-09-030000-00-00NoNoCurrent