proparacaine hydrochloride
Alcaine (proparacaine hydrochloride ophthalmic solution, USP) 0.5%
Approved
Approval ID
9a67a989-ec6b-4a26-e053-2a95a90a826d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 22, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-5139
Application NumberANDA080027
Product Classification
M
Marketing Category
C73584
G
Generic Name
proparacaine hydrochloride
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateFebruary 22, 2021
FDA Product Classification
INGREDIENTS (6)
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
PROPARACAINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 mL
Code: U96OL57GOY
Classification: ACTIB