Citanest Forte
Citanest Forte (prilocaine and epinephrine bitartrate injection, solution)
Approved
Approval ID
a654df2a-68bc-43c5-bd97-ad43f8679dc0
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 17, 2017
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 and epinephrine bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code66312-540
Application NumberNDA021383
Product Classification
M
Marketing Category
C73594
G
Generic Name
prilocaine hydrochloride and epinephrine bitartrate
Product Specifications
Route of AdministrationSUBMUCOSAL
Effective DateOctober 17, 2017
FDA Product Classification
INGREDIENTS (5)
PRILOCAINE HYDROCHLORIDEActive
Quantity: 40 mg in 1 mL
Code: MJW015BAPH
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Quantity: 0.2 mg in 1 mL
Code: 2968PHW8QP
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
EPINEPHRINE BITARTRATEActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM