MOXIFLOXACIN
MOXIFLOXACIN
Approved
Approval ID
723771a2-3e9a-e6f3-e053-2a91aa0a4d21
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 30, 2018
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
MOXIFLOXACIN
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-553
Application NumberANDA090080
Product Classification
M
Marketing Category
C73584
G
Generic Name
MOXIFLOXACIN
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 30, 2018
FDA Product Classification
INGREDIENTS (6)
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
MOXIFLOXACIN HYDROCHLORIDE MONOHYDRATEActive
Quantity: 5 mg in 1 mL
Code: B8956S8609
Classification: ACTIB