Prilocaine Hydrochloride
Prilocaine Hydrochloride Injection, USP, 4%
Approved
Approval ID
ca454f96-2e2d-46ed-95af-c741726773de
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 8, 2010
Manufacturers
FDA
Septodont Inc.
DUNS: 627058738
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 Code0362-9014
Application NumberANDA079235
Product Classification
M
Marketing Category
C73584
G
Generic Name
prilocaine hydrochloride
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateOctober 8, 2010
FDA Product Classification
INGREDIENTS (4)
prilocaine hydrochlorideActive
Quantity: 40 mg in 1 mL
Code: MJW015BAPH
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT