Prilocaine Hydrochloride with Epinephrine
Prilocaine HCl 4% with Epinephrine 1:200,000 Injection
Approved
Approval ID
b374a5f1-ef37-402d-b011-ca8d20689f02
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 1, 2011
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 and epinephrine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0362-9013
Application NumberANDA078959
Product Classification
M
Marketing Category
C73584
G
Generic Name
prilocaine and epinephrine
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateSeptember 1, 2011
FDA Product Classification
INGREDIENTS (7)
SODIUM METABISULFITEInactive
Quantity: 0.5 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
Epinephrine BitartrateActive
Quantity: 0.005 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIB
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
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT