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
NDC Product Code13985-611
Application NumberANDA040277
Marketing CategoryC73584
Route of AdministrationOPHTHALMIC
Effective DateMarch 27, 2015
Generic NameProparacaine Hydrochloride
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