Pearson Mepivacaine
Mepivacaine HCl 3% (Mepivacaine Hydrochloride Injection, USP)
Approved
Approval ID
d303afcf-73b3-4dbf-88c9-0ae20f0d879a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 30, 2017
Manufacturers
FDA
Pearson Dental
DUNS: 082874108
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Mepivacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code43305-1080
Application NumberANDA088387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Mepivacaine Hydrochloride
Product Specifications
Route of AdministrationSUBCUTANEOUS
Effective DateNovember 30, 2017
FDA Product Classification
INGREDIENTS (3)
Mepivacaine HydrochlorideActive
Quantity: 30 mg in 1 mL
Code: 4VFX2L7EM5
Classification: ACTIB
Sodium ChlorideInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT