RANITIDINE
Ranitidine Syrup (Ranitidine Oral Solution, USP)
Approved
Approval ID
d14996b3-832a-4123-8ded-60d4657ee099
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 13, 2012
Manufacturers
FDA
WOCKHARDT USA LLC
DUNS: 170508365
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 Code64679-694
Application NumberANDA079211
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateJanuary 19, 2011
Generic NameRANITIDINE HYDROCHLORIDE
INGREDIENTS (12)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
RANITIDINE HYDROCHLORIDEActive
Quantity: 15 mg in 1 mL
Code: BK76465IHM
Classification: ACTIM
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SODIUM PHOSPHATE, DIBASIC ANHYDROUSInactive
Code: 22ADO53M6F
Classification: IACT
POTASSIUM PHOSPHATE, MONOBASICInactive
Code: 4J9FJ0HL51
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TY
Classification: IACT
PEPPERMINTInactive
Code: V95R5KMY2B
Classification: IACT