Citalopram
Citalopram Tablets, USP 10 mg, 20 mg, and 40 mg Rx Only
Approved
Approval ID
94bb1159-f716-4479-83df-5728c6806c6e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 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 hydrobromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code53808-1037
Application NumberANDA077046
Product Classification
M
Marketing Category
C73584
G
Generic Name
citalopram hydrobromide
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 30, 2014
FDA Product Classification
INGREDIENTS (7)
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)Inactive
Code: 8136Y38GY5
Classification: IACT
POLYETHYLENE GLYCOL 8000Inactive
Code: Q662QK8M3B
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT