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Ketamine Hydrochloride

These highlights do not include all the information needed to useKETAMINE HYDROCHLORIDE INJECTION, safely and effectively. See full prescribing information for KETAMINE HYDROCHLORIDE INJECTION. KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CIIIInitial U.S. Approval: 1970

Approved
Approval ID

902c3785-a3cb-472b-ac15-394ac646271d

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

May 1, 2023

Manufacturers
FDA

Sagent Pharmaceuticals

DUNS: 080579617

Products 3

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Ketamine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25021-683
Application NumberANDA216809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 1, 2023
FDA Product Classification

INGREDIENTS (2)

Ketamine HydrochlorideActive
Quantity: 50 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
Benzethonium ChlorideInactive
Code: PH41D05744
Classification: IACT

Ketamine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25021-684
Application NumberANDA216809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 1, 2023
FDA Product Classification

INGREDIENTS (2)

Ketamine HydrochlorideActive
Quantity: 100 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
Benzethonium ChlorideInactive
Code: PH41D05744
Classification: IACT

Ketamine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code25021-682
Application NumberANDA216809
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ketamine Hydrochloride
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateMay 1, 2023
FDA Product Classification

INGREDIENTS (3)

Ketamine HydrochlorideActive
Quantity: 10 mg in 1 mL
Code: O18YUO0I83
Classification: ACTIM
Benzethonium ChlorideInactive
Code: PH41D05744
Classification: IACT
Sodium ChlorideInactive
Code: 451W47IQ8X
Classification: IACT

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