Citalopram
Citalopram Tablets, USP
Approved
Approval ID
17b2ac2b-f709-433b-961f-57a8dbe1c36a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 13, 2011
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
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 Code42254-066
Application NumberANDA077534
Product Classification
M
Marketing Category
C73584
G
Generic Name
Citalopram
Product Specifications
Route of AdministrationORAL
Effective DateAugust 17, 2011
FDA Product Classification
INGREDIENTS (11)
COPOVIDONE K25-31Inactive
Code: D9C330MD8B
Classification: IACT
CROSCARMELLOSE SODIUMInactive
Code: M28OL1HH48
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
HYPROMELLOSE 2910 (3 MPA.S)Inactive
Code: 0VUT3PMY82
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
HYPROMELLOSE 2910 (6 MPA.S)Inactive
Code: 0WZ8WG20P6
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CITALOPRAM HYDROBROMIDEActive
Quantity: 40 mg in 1 1
Code: I1E9D14F36
Classification: ACTIM
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT