Citalopram Hydrobromide

Product NDC
66116-352
11-digit product format
661160352
Labeler code
66116
Product ID
66116-352_ab1bacf9-00fa-4332-8cb8-a5071b2a7723
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
MedVantx, Inc.
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
E
Listing certified through
2017-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66116-352-302019-11-27C16284748780-19855d018-e861-cd31-e053-dbdaa90ab51aCitalopram Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66116-352-30Citalopram Hydrobromide30 in 1 BOTTLETABLET, FILM COATED301

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 Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66116-352CITALOPRAM HYDROBROMIDE TABLET, FILM COATED [MEDVANTX, INC.]1Legacy NDC, 1 package rows20130821_ab1bacf9-00fa-4332-8cb8-a5071b2a7723.zip

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 formatDescriptionStatus
66116-352-306611603523030 in 1 BOTTLEHistorical