CITALOPRAM
Rx only
Approved
Approval ID
22edd948-d2fe-4df1-b797-1b7d92fc29cf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2019
Manufacturers
FDA
International Laboratories, LLC
DUNS: 023569924
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CITALOPRAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-889
Application NumberANDA077038
Product Classification
M
Marketing Category
C73584
G
Generic Name
CITALOPRAM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2018
FDA Product Classification
INGREDIENTS (12)
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CITALOPRAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-980
Application NumberANDA077038
Product Classification
M
Marketing Category
C73584
G
Generic Name
CITALOPRAM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2018
FDA Product Classification
INGREDIENTS (13)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 20 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CITALOPRAM
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54458-981
Application NumberANDA077038
Product Classification
M
Marketing Category
C73584
G
Generic Name
CITALOPRAM
Product Specifications
Route of AdministrationORAL
Effective DateOctober 12, 2018
FDA Product Classification
INGREDIENTS (15)
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
HYPROMELLOSE 2910 (5 MPA.S)Inactive
Code: R75537T0T4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT