Citalopram
Citalopram Tablets, USP
Approved
Approval ID
5ae13bf8-8b87-453c-aba1-9bbfbdd13d17
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 30, 2014
Manufacturers
FDA
State of Florida DOH Central Pharmacy
DUNS: 829348114
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 Code53808-1077
Application NumberANDA077289
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram
Product Specifications
Route of AdministrationORAL
Effective DateDecember 30, 2014
FDA Product Classification
INGREDIENTS (12)
POVIDONE K12Inactive
Code: 333AG72FWJ
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT