Citalopram

Product NDC
82009-106
11-digit product format
820090106
Labeler code
82009
Product ID
82009-106_f85b3b65-e283-4270-895c-c601b6e7c6a6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
QUALLENT PHARMACEUTICALS HEALTH LLC
Application
ANDA077031
Marketing category
ANDA
Marketing start
2023-08-01
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC], Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui200371, 283672, 309314

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
82009-106-05Citalopram500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82009-106CITALOPRAM (CITALOPRAM HYDROBROMIDE) TABLET, FILM COATED [QUALLENT PHARMACEUTICALS HEALTH LLC]4Current NDC, 1 package rows20240723_e0822069-9672-4d4c-bc1a-8739b0dd045c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
283672citalopram 10 MG Oral TabletPSNe0822069-9672-4d4c-bc1a-8739b0dd045c4
200371citalopram 20 MG Oral TabletPSNe0822069-9672-4d4c-bc1a-8739b0dd045c4
309314citalopram 40 MG Oral TabletPSNe0822069-9672-4d4c-bc1a-8739b0dd045c4
283672citalopram 10 MG Oral TabletSCDe0822069-9672-4d4c-bc1a-8739b0dd045c4
200371citalopram 20 MG Oral TabletSCDe0822069-9672-4d4c-bc1a-8739b0dd045c4
309314citalopram 40 MG Oral TabletSCDe0822069-9672-4d4c-bc1a-8739b0dd045c4
283672citalopram 10 MG (as citalopram HBr 12.49 MG) Oral TabletSYe0822069-9672-4d4c-bc1a-8739b0dd045c4
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYe0822069-9672-4d4c-bc1a-8739b0dd045c4
309314citalopram 40 MG (as citalopram HBr 49.98 MG) Oral TabletSYe0822069-9672-4d4c-bc1a-8739b0dd045c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82009-106-0582009010605500 TABLET, FILM COATED in 1 BOTTLE (82009-106-05) 2023-08-01NoNoHistorical