ketamine hydrochloride

Generic: ketamine hydrochloride

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

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler fresenius kabi usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 100 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 65219-186
Product ID 65219-186_9acdebb0-6e88-42b2-ac45-da51aaad0f3c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215808
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-07-10

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 65219186
Hyphenated Format 65219-186

Supplemental Identifiers

RxCUI
238082 238083 238084
UPC
0365219186014 0365219184010 0365219188018
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 ANDA215808 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 TRAY (65219-186-05) / 5 mL in 1 VIAL (65219-186-01)
source: ndc

Packages (1)

65219-186-05 10 VIAL in 1 TRAY (65219-186-05) / 5 mL in 1 VIAL (65219-186-01)

Ingredients (1)

ketamine hydrochloride (100 mg/mL)

Linked Drug Pages (2)

ketamine hydrochloride ndc-match (0.9) ketamine hydrochloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "9acdebb0-6e88-42b2-ac45-da51aaad0f3c", "openfda": {"upc": ["0365219186014", "0365219184010", "0365219188018"], "unii": ["O18YUO0I83"], "rxcui": ["238082", "238083", "238084"], "spl_set_id": ["cc67b0fd-ca73-49f6-b5ca-705dc7331776"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 TRAY (65219-186-05)  / 5 mL in 1 VIAL (65219-186-01)", "package_ndc": "65219-186-05", "marketing_start_date": "20250418"}], "brand_name": "ketamine hydrochloride", "product_id": "65219-186_9acdebb0-6e88-42b2-ac45-da51aaad0f3c", "dosage_form": "INJECTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "65219-186", "dea_schedule": "CIII", "generic_name": "ketamine hydrochloride", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ketamine hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "100 mg/mL"}], "application_number": "ANDA215808", "marketing_category": "ANDA", "marketing_start_date": "20230710", "listing_expiration_date": "20261231"}