Citalopram hydrobromide

Product NDC
68645-282
11-digit product format
686450282
Labeler code
68645
Product ID
68645-282_9e60b794-bc6a-40f2-87a1-7d4679535f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Legacy Pharmaceutical Packaging
Application
ANDA077038
Marketing category
ANDA
Marketing start
2010-10-01
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
2019-12-31
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
68645-282-542020-01-31C16284748780-19d75b9d0-2e3f-f424-e053-dadaa90a57ceCitalopram Tablets, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68645-282-54Citalopram hydrobromide30 in 1 BOTTLETABLET305

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68645-282-54EA - Each68645-282f1931bf6-ab27-46e7-802d-786b43b85f2a12012-07-24

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68645-282CITALOPRAM HYDROBROMIDE TABLET [LEGACY PHARMACEUTICAL PACKAGING]5Legacy NDC, 1 package rows20120308_399c2713-4ed0-4be7-87f7-f32450d03fba.zip

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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68645-282-546864502825430 in 1 BOTTLEHistorical