ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler eugia us llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 50 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-439
Product ID 55150-439_35913e3d-e141-4596-bc4c-72deb8cbf932
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA076092
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2021-03-15

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150439
Hyphenated Format 55150-439

Supplemental Identifiers

RxCUI
238082 238083 238084
UNII
O18YUO0I83

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 ketamine hydrochloride (source: ndc)
Generic Name ketamine hydrochloride (source: ndc)
Application Number ANDA076092 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 CARTON (55150-439-10) / 10 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

55150-439-10 10 VIAL, MULTI-DOSE in 1 CARTON (55150-439-10) / 10 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

ketamine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

KETAMINE HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "35913e3d-e141-4596-bc4c-72deb8cbf932", "openfda": {"unii": ["O18YUO0I83"], "rxcui": ["238082", "238083", "238084"], "spl_set_id": ["f8b01c77-620d-4734-a771-b8524b65bcca"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 CARTON (55150-439-10)  / 10 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55150-439-10", "marketing_start_date": "20210315"}], "brand_name": "KETAMINE HYDROCHLORIDE", "product_id": "55150-439_35913e3d-e141-4596-bc4c-72deb8cbf932", "dosage_form": "INJECTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "55150-439", "dea_schedule": "CIII", "generic_name": "KETAMINE HYDROCHLORIDE", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "KETAMINE HYDROCHLORIDE", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA076092", "marketing_category": "ANDA", "marketing_start_date": "20210315", "listing_expiration_date": "20261231"}