ketalar

Generic: ketamine hydrochloride

Labeler: par health usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketalar
Generic Name ketamine hydrochloride
Labeler par health usa, llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 10 mg/mL

Manufacturer
Par Health USA, LLC

Identifiers & Regulatory

Product NDC 42023-113
Product ID 42023-113_0f521490-2803-43cd-baf9-e0ab303694d0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA016812
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2007-10-01

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 42023113
Hyphenated Format 42023-113

Supplemental Identifiers

RxCUI
206967 206970 206972 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 ketalar (source: ndc)
Generic Name ketamine hydrochloride (source: ndc)
Application Number NDA016812 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL
source: ndc

Packages (1)

42023-113-10 10 VIAL in 1 CARTON (42023-113-10) / 20 mL in 1 VIAL

Ingredients (1)

ketamine hydrochloride (10 mg/mL)

Linked Drug Pages (1)

Ketalar ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "0f521490-2803-43cd-baf9-e0ab303694d0", "openfda": {"unii": ["O18YUO0I83"], "rxcui": ["206967", "206970", "206972", "238082", "238083", "238084"], "spl_set_id": ["14e8f864-8b8a-4e7e-8439-e510d3107063"], "manufacturer_name": ["Par Health USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (42023-113-10)  / 20 mL in 1 VIAL", "package_ndc": "42023-113-10", "marketing_start_date": "20071001"}], "brand_name": "Ketalar", "product_id": "42023-113_0f521490-2803-43cd-baf9-e0ab303694d0", "dosage_form": "INJECTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "42023-113", "dea_schedule": "CIII", "generic_name": "ketamine hydrochloride", "labeler_name": "Par Health USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketalar", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "NDA016812", "marketing_category": "NDA", "marketing_start_date": "20071001", "listing_expiration_date": "20261231"}