ALOMIDE
ALOMIDE (lodoxamide tromethamine ophthalmic solution) 0.1%
Approved
Approval ID
74317375-53a5-44f7-91ea-aa5f5cfe1851
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 10, 2023
Manufacturers
FDA
Novartis Pharmaceuticals Corporation
DUNS: 002147023
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lodoxamide tromethamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0078-0736
Application NumberNDA020191
Product Classification
M
Marketing Category
C73594
G
Generic Name
lodoxamide tromethamine
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 15, 2022
FDA Product Classification
INGREDIENTS (11)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TYLOXAPOLInactive
Code: Y27PUL9H56
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
LODOXAMIDE TROMETHAMINEActive
Quantity: 1 mg in 1 mL
Code: 50LV9A548L
Classification: ACTIM
BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
MANNITOLInactive
Code: 3OWL53L36A
Classification: IACT
HYPROMELLOSE 2910 (4000 MPA.S)Inactive
Code: RN3152OP35
Classification: IACT
SODIUM CITRATEInactive
Code: 1Q73Q2JULR
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 8/15/2022
PRINCIPAL DISPLAY PANEL
NDC 0078-0736-10
Alomide®
0.1%
(lodoxamide tromethamine ophthalmic solution)
10 mL Sterile
NOVARTIS
