etomidate

Generic: etomidate injection

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name etomidate
Generic Name etomidate injection
Labeler gland pharma limited
Dosage Form SOLUTION
Routes
INTRAVENOUS
Active Ingredients

etomidate 2 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-235
Product ID 68083-235_3e4fa967-6ab9-4de0-af94-f9c479504b20
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209058
Listing Expiration 2026-12-31
Marketing Start 2017-05-20

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083235
Hyphenated Format 68083-235

Supplemental Identifiers

RxCUI
1654006 1654008
UPC
0368083235017 0368083234010
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 injection (source: ndc)
Application Number ANDA209058 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 2 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-235-10) / 20 mL in 1 VIAL (68083-235-01)
source: ndc

Packages (1)

68083-235-10 10 VIAL in 1 CARTON (68083-235-10) / 20 mL in 1 VIAL (68083-235-01)

Ingredients (1)

etomidate (2 mg/mL)

Linked Drug Pages (1)

Etomidate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "3e4fa967-6ab9-4de0-af94-f9c479504b20", "openfda": {"nui": ["N0000175975", "N0000175681"], "upc": ["0368083235017", "0368083234010"], "unii": ["Z22628B598"], "rxcui": ["1654006", "1654008"], "spl_set_id": ["94cde4e7-3b46-419f-8dda-87675da8d89d"], "pharm_class_pe": ["General Anesthesia [PE]"], "pharm_class_epc": ["General Anesthetic [EPC]"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-235-10)  / 20 mL in 1 VIAL (68083-235-01)", "package_ndc": "68083-235-10", "marketing_start_date": "20170520"}], "brand_name": "Etomidate", "product_id": "68083-235_3e4fa967-6ab9-4de0-af94-f9c479504b20", "dosage_form": "SOLUTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "68083-235", "generic_name": "Etomidate Injection", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Etomidate", "active_ingredients": [{"name": "ETOMIDATE", "strength": "2 mg/mL"}], "application_number": "ANDA209058", "marketing_category": "ANDA", "marketing_start_date": "20170520", "listing_expiration_date": "20261231"}