Ranitidine
Ranitidine Syrup (Ranitidine Oral Solution, USP) 15 mg/mL
Approved
Approval ID
804ba82f-aaf6-46ec-8765-341c5ee2942a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 15, 2010
Manufacturers
FDA
Atlantic Biologicals Corps
DUNS: 047437707
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code17856-0664
Application NumberANDA078312
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ranitidine
Product Specifications
Route of AdministrationORAL
Effective DateJune 15, 2010
FDA Product Classification
INGREDIENTS (12)
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 mL
Code: BK76465IHM
Classification: ACTIM
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM PHOSPHATE, MONOBASICInactive
Code: 3980JIH2SW
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT