Label: CITALOPRAM tablet, film coated
- NDC Code(s): 61919-288-30
- Packager: DIRECT RX
- This is a repackaged label.
- Source NDC Code(s): 65162-052
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 12, 2016
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DESCRIPTION
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
- PRECAUTIONS
- ADVERSE REACTIONS
- ADVERSE REACTIONS PART 2
- DRUG ABUSE AND DEPENDENCE
- OVERDOSAGE
- DOSAGE AND ADMINISTRATION
- ANIMAL TOXICOLOGY
- Medication Guide
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CITALOPRAM
citalopram tablet, film coatedProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61919-288(NDC:65162-052) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CITALOPRAM HYDROBROMIDE (UNII: I1E9D14F36) (CITALOPRAM - UNII:0DHU5B8D6V) CITALOPRAM 10 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POLYVINYL ALCOHOL (UNII: 532B59J990) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERRIC OXIDE RED (UNII: 1K09F3G675) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) STARCH, CORN (UNII: O8232NY3SJ) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) TALC (UNII: 7SEV7J4R1U) POVIDONE K12 (UNII: 333AG72FWJ) Product Characteristics Color orange Score no score Shape OVAL Size 12mm Flavor Imprint Code IP;52 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61919-288-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 03/22/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA077289 03/22/2016 Labeler - DIRECT RX (079254320) Establishment Name Address ID/FEI Business Operations DIRECT RX 079254320 repack(61919-288)
