ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION, CONCENTRATE
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 50 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-2053
Product ID 0409-2053_37921fa5-8ef5-4af7-bf99-3a9ab24fa752
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074549
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2004-11-30

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04092053
Hyphenated Format 0409-2053

Supplemental Identifiers

RxCUI
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 ANDA074549 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL, MULTI-DOSE in 1 BOX (0409-2053-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20)
source: ndc

Packages (1)

0409-2053-10 10 VIAL, MULTI-DOSE in 1 BOX (0409-2053-10) / 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20)

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": "37921fa5-8ef5-4af7-bf99-3a9ab24fa752", "openfda": {"unii": ["O18YUO0I83"], "rxcui": ["238083", "238084"], "spl_set_id": ["bb912318-2e22-4469-b0a2-774803ee1bb8"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL, MULTI-DOSE in 1 BOX (0409-2053-10)  / 10 mL in 1 VIAL, MULTI-DOSE (0409-2053-20)", "package_ndc": "0409-2053-10", "marketing_start_date": "20041130"}], "brand_name": "Ketamine Hydrochloride", "product_id": "0409-2053_37921fa5-8ef5-4af7-bf99-3a9ab24fa752", "dosage_form": "INJECTION, SOLUTION, CONCENTRATE", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "0409-2053", "dea_schedule": "CIII", "generic_name": "Ketamine Hydrochloride", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketamine Hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA074549", "marketing_category": "ANDA", "marketing_start_date": "20041130", "listing_expiration_date": "20261231"}