Citanest Plain
4% Citanest Plain DentalPrilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL)(prilocaine HCI Injection, USP)
Approved
Approval ID
db23a56f-1e41-4843-9220-1b2e3059db41
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 10, 2021
Manufacturers
FDA
Dentsply Pharmaceutical Inc.
DUNS: 102221942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
prilocaine hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66312-630
Application NumberANDA079235
Product Classification
M
Marketing Category
C73584
G
Generic Name
prilocaine hydrochloride
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateSeptember 10, 2019
FDA Product Classification
INGREDIENTS (4)
PRILOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: MJW015BAPH
Classification: ACTIB
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
WATERInactive
Quantity: 1 mL in 1 mL
Code: 059QF0KO0R
Classification: IACT