Proparacaine Hydrochloride
apexa™Proparacaine Hydrochloride
Approved
Approval ID
66e8723a-620c-42ed-a43e-cfa30014e1dc
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 4, 2022
Manufacturers
FDA
MWI
DUNS: 019926120
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Proparacaine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code13985-611
Application NumberANDA040277
Product Classification
M
Marketing Category
C73584
G
Generic Name
Proparacaine Hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateMarch 27, 2015
FDA Product Classification
INGREDIENTS (6)
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Proparacaine HydrochlorideActive
Quantity: 5 mg in 1 mL
Code: U96OL57GOY
Classification: ACTIB
Sodium HydroxideInactive
Code: 55X04QC32I
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzalkonium ChlorideInactive
Code: F5UM2KM3W7
Classification: IACT