Nizatidine
Nizatidine Capsules 150 mg and 300 mg
Approved
Approval ID
913524d4-0c3d-0a25-e053-2a95a90aa8b8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 19, 2021
Manufacturers
FDA
NuCare Pharmaceuticals,Inc.
DUNS: 010632300
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 Code68071-5043
Application NumberANDA075616
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 19, 2021
FDA Product Classification
INGREDIENTS (15)
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
SHELLACInactive
Code: 46N107B71O
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
NIZATIDINEActive
Quantity: 150 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT