FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
55111-344
11-digit product format
551110344
Labeler code
55111
Product ID
55111-344_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
40 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
55111-344-01EA - Each55111-3447adfd5bd-8df4-410a-854d-8b1f0b773e1012012-07-24
55111-344-05EA - Each55111-34488046c72-df1e-4222-afee-abc210056be212012-07-24
55111-344-30EA - Each55111-344bc2f8088-e51d-46e2-885b-bcbf2429fc1d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ACITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5
Citalopram hydrobromideACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
Citalopram hydrobromideACTIVE INGREDIENTI1E9D14F36CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
CitalopramACTIVE MOIETY0DHU5B8D6VCITALOPRAM 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
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
Copovidone K25-31INACTIVE INGREDIENTD9C330MD8BCITALOPRAM 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
croscarmellose sodiumINACTIVE INGREDIENTM28OL1HH48CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
HYPROMELLOSE 2910 (5 MPA.S)INACTIVE INGREDIENTR75537T0T4CITALOPRAM 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
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
lactose monohydrateINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM 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
magnesium stearateINACTIVE INGREDIENT70097M6I30CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
polyethylene glycol 400INACTIVE INGREDIENTB697894SGQCITALOPRAM 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
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1
starch, cornINACTIVE INGREDIENTO8232NY3SJCITALOPRAM 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
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309314citalopram 40 MG Oral TabletPSN399c2713-4ed0-4be7-87f7-f32450d03fba5
309314citalopram 40 MG Oral TabletSCD399c2713-4ed0-4be7-87f7-f32450d03fba5
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY399c2713-4ed0-4be7-87f7-f32450d03fba5
309314citalopram 40 MG Oral TabletPSN197c51b6-d0b8-4cd6-89f6-be666168092c1
309314citalopram 40 MG Oral TabletPSN9171c747-d032-4732-b067-17cd9c77357a1
309314citalopram 40 MG Oral TabletSCD197c51b6-d0b8-4cd6-89f6-be666168092c1
309314citalopram 40 MG Oral TabletSCD9171c747-d032-4732-b067-17cd9c77357a1
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY197c51b6-d0b8-4cd6-89f6-be666168092c1
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSY9171c747-d032-4732-b067-17cd9c77357a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55111-344-0155111034401100 TABLET, FILM COATED in 1 BOTTLE (55111-344-01) 2004-10-280000-00-00NoNoCurrent
55111-344-0555111034405500 TABLET, FILM COATED in 1 BOTTLE (55111-344-05) 2004-10-280000-00-00NoNoCurrent
55111-344-305511103443030 TABLET, FILM COATED in 1 BOTTLE (55111-344-30) 2004-10-280000-00-00NoNoCurrent
55111-344-605511103446060 TABLET, FILM COATED in 1 BOTTLE (55111-344-60) 2004-10-280000-00-00NoNoCurrent
55111-344-785511103447810 BLISTER PACK in 1 CARTON (55111-344-78) > 10 TABLET, FILM COATED in 1 BLISTER PACK (55111-344-79) 10 blister pack2004-10-280000-00-00NoNoCurrent