Nizatidine
NIZATIDINE CAPSULES
Approved
Approval ID
faaa7cc4-fda9-d5b8-de2a-71c8744ccb76
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 6, 2018
Manufacturers
FDA
Dr Reddy's Laboratories Limited
DUNS: 650562841
Products 2
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 Code55111-310
Application NumberANDA077314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2018
FDA Product Classification
INGREDIENTS (18)
NizatidineActive
Quantity: 150 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
povidoneInactive
Code: FZ989GH94E
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C red no. 28Inactive
Code: 767IP0Y5NH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
FD&C blue no. 2Inactive
Code: L06K8R7DQK
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Nizatidine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code55111-311
Application NumberANDA077314
Product Classification
M
Marketing Category
C73584
G
Generic Name
Nizatidine
Product Specifications
Route of AdministrationORAL
Effective DateDecember 6, 2018
FDA Product Classification
INGREDIENTS (18)
croscarmellose sodiumInactive
Code: M28OL1HH48
Classification: IACT
NizatidineActive
Quantity: 300 mg in 1 1
Code: P41PML4GHR
Classification: ACTIB
povidoneInactive
Code: FZ989GH94E
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
dimethiconeInactive
Code: 92RU3N3Y1O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GelatinInactive
Code: 2G86QN327L
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C red no. 40Inactive
Code: WZB9127XOA
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Isopropyl AlcoholInactive
Code: ND2M416302
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Butyl AlcoholInactive
Code: 8PJ61P6TS3
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
Ferrosoferric OxideInactive
Code: XM0M87F357
Classification: IACT