FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
55700-851
11-digit product format
557000851
Labeler code
55700
Product ID
55700-851_4e97913b-40ba-4158-a875-65496725b4e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET
Route
ORAL
Labeler
Quality Care Products, LLC
Application
ANDA078216
Marketing category
ANDA
Marketing start
2020-03-20
Marketing end
2026-10-31
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram Hydrobromide

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55700-851-30Citalopram Hydrobromide30 in 1 BOTTLETABLET307
55700-851-90Citalopram Hydrobromide90 in 1 BOTTLETABLET907

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55700-851-30EA - Each55700-851b4c8af39-bf2b-41c8-ba43-461ea30ef5ac12020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-851CITALOPRAM HYDROBROMIDE TABLET [QUALITY CARE PRODUCTS, LLC]7Current NDC, Legacy NDC, 2 package rows20241220_6fc110ba-87e7-404e-9e00-b680f354c7b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSN6fc110ba-87e7-404e-9e00-b680f354c7b07
200371citalopram 20 MG Oral TabletSCD6fc110ba-87e7-404e-9e00-b680f354c7b07
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY6fc110ba-87e7-404e-9e00-b680f354c7b07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-851-305570008513030 TABLET in 1 BOTTLE (55700-851-30) 30 tablet2020-03-200000-00-00NoNoCurrent
55700-851-905570008519090 TABLET in 1 BOTTLE (55700-851-90) 90 tablet2020-08-202026-10-31NoNoCurrent