Nizatidine
Nizatidine Capsules 300 mg
Approved
Approval ID
487b4138-f7db-480f-96d2-8010fd5c0c06
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 9, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Nizatidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-043
Application NumberANDA075616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 12, 2011
FDA Product Classification
INGREDIENTS (15)
NIZATIDINEActive
Quantity: 300 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT