ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: gland pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler gland pharma limited
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 10 mg/mL

Manufacturer
Gland Pharma Limited

Identifiers & Regulatory

Product NDC 68083-504
Product ID 68083-504_5a07aea6-9e9a-4788-9a14-e624b4f86bc0
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216809
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-01-24

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68083504
Hyphenated Format 68083-504

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 ANDA216809 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (68083-504-10) / 20 mL in 1 VIAL
source: ndc

Packages (1)

68083-504-10 10 VIAL in 1 CARTON (68083-504-10) / 20 mL in 1 VIAL

Ingredients (1)

ketamine hydrochloride (10 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": "5a07aea6-9e9a-4788-9a14-e624b4f86bc0", "openfda": {"unii": ["O18YUO0I83"], "rxcui": ["238082", "238083", "238084"], "spl_set_id": ["b96a0a23-3ca0-4a92-bd8b-1e9921931772"], "manufacturer_name": ["Gland Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (68083-504-10)  / 20 mL in 1 VIAL", "package_ndc": "68083-504-10", "marketing_start_date": "20230124"}], "brand_name": "Ketamine Hydrochloride", "product_id": "68083-504_5a07aea6-9e9a-4788-9a14-e624b4f86bc0", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "68083-504", "dea_schedule": "CIII", "generic_name": "Ketamine Hydrochloride", "labeler_name": "Gland Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketamine Hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "10 mg/mL"}], "application_number": "ANDA216809", "marketing_category": "ANDA", "marketing_start_date": "20230124", "listing_expiration_date": "20261231"}