CITALOPRAM
CITALOPRAM 10mg 30 TABS
Approved
Approval ID
304f1d5a-218f-51ae-e054-00144ff88e88
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2016
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
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code61919-288
Application NumberANDA077289
Product Classification
M
Marketing Category
C73584
G
Generic Name
CITALOPRAM
Product Specifications
Route of AdministrationORAL
Effective DateApril 12, 2016
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FERRIC OXIDE YELLOWInactive
Code: EX438O2MRT
Classification: IACT
FERRIC OXIDE REDInactive
Code: 1K09F3G675
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 10 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT