ketamine hydrochloride

Generic: ketamine hydrochloride

Labeler: sagent pharmaceuticals
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name ketamine hydrochloride
Generic Name ketamine hydrochloride
Labeler sagent pharmaceuticals
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

ketamine hydrochloride 50 mg/mL

Manufacturer
Sagent Pharmaceuticals

Identifiers & Regulatory

Product NDC 25021-683
Product ID 25021-683_51a16c65-47e0-405c-8c84-82a6a28b3efd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216809
DEA Schedule ciii
Listing Expiration 2026-12-31
Marketing Start 2023-07-15

Pharmacologic Class

Classes
general anesthesia [pe] general anesthetic [epc]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 25021683
Hyphenated Format 25021-683

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
  • 50 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL
source: ndc

Packages (1)

25021-683-10 10 VIAL in 1 CARTON (25021-683-10) / 10 mL in 1 VIAL

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": "51a16c65-47e0-405c-8c84-82a6a28b3efd", "openfda": {"unii": ["O18YUO0I83"], "rxcui": ["238082", "238083", "238084"], "spl_set_id": ["902c3785-a3cb-472b-ac15-394ac646271d"], "manufacturer_name": ["Sagent Pharmaceuticals"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (25021-683-10)  / 10 mL in 1 VIAL", "package_ndc": "25021-683-10", "marketing_start_date": "20230715"}], "brand_name": "Ketamine Hydrochloride", "product_id": "25021-683_51a16c65-47e0-405c-8c84-82a6a28b3efd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["General Anesthesia [PE]", "General Anesthetic [EPC]"], "product_ndc": "25021-683", "dea_schedule": "CIII", "generic_name": "Ketamine Hydrochloride", "labeler_name": "Sagent Pharmaceuticals", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Ketamine Hydrochloride", "active_ingredients": [{"name": "KETAMINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "ANDA216809", "marketing_category": "ANDA", "marketing_start_date": "20230715", "listing_expiration_date": "20261231"}