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
NDC Product Code17856-0664
Application NumberANDA078312
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJune 15, 2010
Generic NameRanitidine
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