Nizatidine
Nizatidine Capsules USP
Approved
Approval ID
1d6161e3-2ddb-5446-e054-00144ff8d46c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 15, 2015
Manufacturers
FDA
Medsource Pharmaceuticals
DUNS: 833685915
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 Code45865-374
Application NumberANDA090618
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 15, 2015
FDA Product Classification
INGREDIENTS (9)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
NIZATIDINEActive
Quantity: 150 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT