FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
55700-787
11-digit product format
557000787
Labeler code
55700
Product ID
55700-787_cace2491-2e54-4b8a-a5a3-682d282524ff
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
2019-08-30
Marketing end
2027-09-30
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 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 HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui283672

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
55700-787-30Citalopram Hydrobromide30 in 1 BOTTLETABLET307
55700-787-60Citalopram Hydrobromide60 in 1 BOTTLETABLET607
55700-787-90Citalopram Hydrobromide90 in 1 BOTTLETABLET907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55700-787CITALOPRAM HYDROBROMIDE TABLET [QUALITY CARE PRODUCTS, LLC]7Current NDC, Legacy NDC, 3 package rows20241220_e22fe468-5d9e-4ec7-a69b-4988e0b8acbd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNe22fe468-5d9e-4ec7-a69b-4988e0b8acbd7
283672citalopram 10 MG Oral TabletSCDe22fe468-5d9e-4ec7-a69b-4988e0b8acbd7
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYe22fe468-5d9e-4ec7-a69b-4988e0b8acbd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55700-787-305570007873030 TABLET in 1 BOTTLE (55700-787-30) 30 tablet2019-08-302027-09-30NoNoCurrent
55700-787-605570007876060 TABLET in 1 BOTTLE (55700-787-60) 60 tablet2020-07-282026-05-31NoNoCurrent
55700-787-905570007879090 TABLET in 1 BOTTLE (55700-787-90) 90 tablet2019-08-302027-09-30NoNoCurrent