Citalopram Hydrobromide
Citalopram Tablets USP
Approved
Approval ID
3993eb55-f0e8-496c-a496-19dc509699e8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Citalopram Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-116
Application NumberANDA078216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (13)
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
Citalopram Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-119
Application NumberANDA078216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Citalopram Hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42254-108
Application NumberANDA078216
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram Hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 22, 2011
FDA Product Classification
INGREDIENTS (13)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSESInactive
Code: 3NXW29V3WO
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT