Ranitidine
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP)
Approved
Approval ID
e08bcb41-21de-462e-b8f1-1c3968d97356
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
May 24, 2012
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ranitidine Hydrochloride
PRODUCT DETAILS
NDC Product Code54868-5770
Application NumberANDA091078
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMay 24, 2012
Generic NameRanitidine Hydrochloride
INGREDIENTS (12)
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 150 mg in 1 mL
Code: BK76465IHM
Classification: ACTIM
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
SODIUM PHOSPHATE, DIBASICInactive
Code: GR686LBA74
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT
SACCHARIN SODIUM DIHYDRATEInactive
Code: SB8ZUX40TY
Classification: IACT