etomidate

Generic: etomidate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etomidate
Generic Name etomidate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

etomidate 2 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-445
Product ID 65219-445_446487f1-002e-41d3-846a-67570e797171
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215028
Listing Expiration 2026-12-31
Marketing Start 2023-10-01

Pharmacologic Class

Established (EPC)
general anesthetic [epc]
Physiologic Effect
general anesthesia [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219445
Hyphenated Format 65219-445

Supplemental Identifiers

RxCUI
1654006
UNII
Z22628B598
NUI
N0000175975 N0000175681

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name etomidate (source: ndc)
Generic Name etomidate (source: ndc)
Application Number ANDA215028 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-22) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-12)
source: ndc

Packages (1)

65219-445-22 10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-22) / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-12)

Ingredients (1)

etomidate (2 mg/mL)

Linked Drug Pages (2)

Etomidate ndc-match (0.9) Etomidate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "446487f1-002e-41d3-846a-67570e797171", "openfda": {"nui": ["N0000175975", "N0000175681"], "unii": ["Z22628B598"], "rxcui": ["1654006"], "spl_set_id": ["f38fad46-f2dd-4692-a2a9-a13d0a717bf8"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, SINGLE-DOSE in 1 CARTON (65219-445-22)  / 10 mL in 1 VIAL, SINGLE-DOSE (65219-445-12)", "package_ndc": "65219-445-22", "marketing_start_date": "20231001"}], "brand_name": "Etomidate", "product_id": "65219-445_446487f1-002e-41d3-846a-67570e797171", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "65219-445", "generic_name": "Etomidate", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etomidate", "active_ingredients": [{"name": "ETOMIDATE", "strength": "2 mg/mL"}], "application_number": "ANDA215028", "marketing_category": "ANDA", "marketing_start_date": "20231001", "listing_expiration_date": "20261231"}