ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 50 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9508
Product ID 0143-9508_6ada9356-0968-46df-b067-d95509650c48
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA074524
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 1996-07-01

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439508
Hyphenated Format 0143-9508

Supplemental Identifiers

RxCUI
238083 238084
UPC
0301439508106 0301439509103
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 ANDA074524 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 BOX (0143-9508-10) / 10 mL in 1 VIAL (0143-9508-01)
source: ndc

Packages (1)

0143-9508-10 10 VIAL in 1 BOX (0143-9508-10) / 10 mL in 1 VIAL (0143-9508-01)

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": "6ada9356-0968-46df-b067-d95509650c48", "openfda": {"upc": ["0301439508106", "0301439509103"], "unii": ["O18YUO0I83"], "rxcui": ["238083", "238084"], "spl_set_id": ["58487c78-a641-4278-acc0-343596ee8683"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 BOX (0143-9508-10)  / 10 mL in 1 VIAL (0143-9508-01)", "package_ndc": "0143-9508-10", "marketing_start_date": "19960701"}], "brand_name": "Ketamine Hydrochloride", "product_id": "0143-9508_6ada9356-0968-46df-b067-d95509650c48", "dosage_form": "INJECTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "0143-9508", "dea_schedule": "CIII", "generic_name": "Ketamine Hydrochloride", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketamine Hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA074524", "marketing_category": "ANDA", "marketing_start_date": "19960701", "listing_expiration_date": "20261231"}