LIDOCAINE
Lidocaine (Lidocaine hydrochloride and epinephrine injection, USP)(Lidocaine HCl 2% and Epinephrine 1:50,000 Injection) (Lidocaine HCl 2% and Epinephrine 1:100,000 Injection)
Approved
Approval ID
b2600b2e-e4e1-47f1-81e7-1e3960b3f881
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 7, 2011
Manufacturers
FDA
Novocol Pharmaceutical of Canada, Inc.
DUNS: 201719960
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine Hydrochloride and Epinephrine Bitartrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code51004-1051
Application NumberANDA088390
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine Hydrochloride and Epinephrine Bitartrate
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 7, 2011
FDA Product Classification
INGREDIENTS (7)
Lidocaine HydrochlorideActive
Quantity: 20 mg in 1 mL
Code: V13007Z41A
Classification: ACTIB
Epinephrine BitartrateActive
Quantity: 0.01 mg in 1 mL
Code: 30Q7KI53AK
Classification: ACTIM
Sodium ChlorideInactive
Quantity: 6.5 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
Potassium MetabisulfiteInactive
Quantity: 1.2 mg in 1 mL
Code: 65OE787Q7W
Classification: IACT
Edetate DisodiumInactive
Quantity: 0.25 mg in 1 mL
Code: 7FLD91C86K
Classification: IACT
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT