LIKMEZ
These highlights do not include all the information needed to use LIKMEZ safely and effectively. See full prescribing information for LIKMEZ. LIKMEZ™ (metronidazole) oral suspension Initial U.S. Approval: 1963
Approved
Approval ID
e20c14eb-5361-4a93-ab46-a7bd9aeb9b98
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 18, 2025
Manufacturers
FDA
Saptalis Pharmaceuticals, LLC
DUNS: 080145868
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Metronidazole Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71656-066
Application NumberNDA216755
Product Classification
M
Marketing Category
C73594
G
Generic Name
Metronidazole Oral
Product Specifications
Route of AdministrationORAL
Effective DateApril 18, 2025
FDA Product Classification
INGREDIENTS (13)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
MAGNESIUM ALUMINUM SILICATEInactive
Code: 6M3P64V0NC
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
SODIUM PHOSPHATE DIBASIC DIHYDRATEInactive
Code: 94255I6E2T
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
METRONIDAZOLEActive
Quantity: 100 mg in 1 mL
Code: 140QMO216E
Classification: ACTIB
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/10/2025
BOXED WARNING SECTION
LOINC: 34066-1Updated: 3/10/2025
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/10/2025
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 3/10/2025
WARNINGS AND PRECAUTIONS SECTION
LOINC: 43685-7Updated: 3/10/2025
ADVERSE REACTIONS SECTION
LOINC: 34084-4Updated: 3/10/2025
DRUG INTERACTIONS SECTION
LOINC: 34073-7Updated: 3/10/2025
RECENT MAJOR CHANGES SECTION
LOINC: 43683-2Updated: 3/10/2025
DOSAGE & ADMINISTRATION SECTION
LOINC: 34068-7Updated: 3/10/2025
DOSAGE FORMS & STRENGTHS SECTION
LOINC: 43678-2Updated: 3/10/2025
SPL PATIENT PACKAGE INSERT SECTION
LOINC: 42230-3Updated: 3/10/2025
USE IN SPECIFIC POPULATIONS SECTION
LOINC: 43684-0Updated: 3/10/2025
OVERDOSAGE SECTION
LOINC: 34088-5Updated: 3/10/2025
DESCRIPTION SECTION
LOINC: 34089-3Updated: 3/10/2025
CLINICAL PHARMACOLOGY SECTION
LOINC: 34090-1Updated: 3/10/2025
NONCLINICAL TOXICOLOGY SECTION
LOINC: 43680-8Updated: 3/10/2025
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 3/10/2025
PATIENT COUNSELING INFORMATION
LOINC: 88436-1Updated: 3/10/2025