nizatidine
Nizatidine Capsules USP
Approved
Approval ID
0131d303-52c4-4ea7-a560-b529bb2c1616
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 17, 2011
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 Code21695-375
Application NumberANDA076178
Product Classification
M
Marketing Category
C73584
G
Generic Name
nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateAugust 24, 2010
FDA Product Classification
INGREDIENTS (6)
POVIDONE K30Inactive
Code: U725QWY32X
Classification: IACT
NIZATIDINEActive
Quantity: 150 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT