Citalopram Hydrobromide

Product NDC
55111-343
11-digit product format
551110343
Labeler code
55111
Product ID
55111-343_77a66875-7c9c-8c98-9ddf-99f2bfaac6ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Dr. Reddy's Laboratories Limited
Application
ANDA077038
Marketing category
ANDA
Marketing start
2004-10-28
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55111-343-01EA - Each55111-34391b370ef-97cf-40b5-ad16-7d79ae2c0fa712012-07-24
55111-343-05EA - Each55111-34307d636a8-8c3d-4d0b-a8aa-0f2081c1f85412012-07-24
55111-343-30EA - Each55111-343c0d4ce0b-1bee-46ac-8252-8109c149f1aa12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Citalopram hydrobromideACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CitalopramACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
Copovidone K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
ferric oxide redINACTIVE INGREDIENT1K09F3G675CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNab1bacf9-00fa-4332-8cb8-a5071b2a77231
200371citalopram 20 MG Oral TabletSCDab1bacf9-00fa-4332-8cb8-a5071b2a77231
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYab1bacf9-00fa-4332-8cb8-a5071b2a77231

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-343-0155111034301100 TABLET, FILM COATED in 1 BOTTLE (55111-343-01) 2004-10-280000-00-00NoNoCurrent
55111-343-0555111034305500 TABLET, FILM COATED in 1 BOTTLE (55111-343-05) 2004-10-280000-00-00NoNoCurrent
55111-343-305511103433030 TABLET, FILM COATED in 1 BOTTLE (55111-343-30) 2004-10-280000-00-00NoNoCurrent
55111-343-605511103436060 TABLET, FILM COATED in 1 BOTTLE (55111-343-60) 2004-10-280000-00-00NoNoCurrent
55111-343-785511103437810 BLISTER PACK in 1 CARTON (55111-343-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-343-79) 10 blister pack2004-10-280000-00-00NoNoCurrent