Clorotekal
These highlights do not include all the information needed to use CLOROTEKAL® safely and effectively. See full prescribing information for CLOROTEKAL®. CLOROTEKAL® (chloroprocaine hydrochloride) injection for intrathecal use Initial U.S. Approval: 1955
Approved
Approval ID
90f7a095-f6db-456b-951f-9aee54c5dbc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 2020
Manufacturers
FDA
B. Braun Medical Inc.
DUNS: 002397347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHLOROPROCAINE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0264-7055
Application NumberNDA208791
Product Classification
M
Marketing Category
C73594
G
Generic Name
CHLOROPROCAINE HYDROCHLORIDE
Product Specifications
Route of AdministrationINTRATHECAL
Effective DateSeptember 17, 2018
FDA Product Classification
INGREDIENTS (5)
SODIUM CHLORIDEInactive
Quantity: 7.2 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
NITROGENInactive
Code: N762921K75
Classification: IACT
CHLOROPROCAINE HYDROCHLORIDEActive
Quantity: 10 mg in 1 mL
Code: LT7Z1YW11H
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT