CITALOPRAM HYDROBROMIDE
CITALOPRAM HYDROBROMIDE
Approved
Approval ID
584aacad-7817-4a90-a810-08b33c61ac5a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 22, 2020
Manufacturers
FDA
DIRECT RX
DUNS: 079254320
Products 1
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 Code61919-055
Application NumberANDA077032
Product Classification
M
Marketing Category
C73584
G
Generic Name
CITALOPRAM HYDROBROMIDE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 22, 2020
FDA Product Classification
INGREDIENTS (13)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOL 4000Inactive
Code: 4R4HFI6D95
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM