FDA.reportPublic FDA data

Citalopram Hydrobromide

Product NDC
17856-0564
11-digit product format
178560564
Labeler code
17856
Product ID
17856-0564_34f3a909-1a50-3667-e063-6294a90aa4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram Hydrobromide
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA201450
Marketing category
ANDA
Marketing start
2019-05-31
Substance
CITALOPRAM HYDROBROMIDE
Active strength
10 mg/5mL
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 Hydrobromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CITALOPRAM HYDROBROMIDE10 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI1E9D14F36
Rxcui309313

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-0564-12024-06-05C16284748780-1f386c649-c478-0266-e053-dadaa90a7c1aCITALOPRAM Oral Solution, USP Rx only
17856-0564-12023-01-30C16284748780-1f386c649-c478-0266-e053-dadaa90a7c1aCITALOPRAM Oral Solution, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0564-1Citalopram Hydrobromide72 in 1 BOX, UNIT-DOSESOLUTION724
17856-0564-1Citalopram Hydrobromide10 mL in 1 CUP, UNIT-DOSESOLUTION104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0564CITALOPRAM HYDROBROMIDE SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Current NDC, Legacy NDC, 2 package rows20250514_2640311d-8b88-4513-9c80-a08390b8142a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309313citalopram 10 MG in 5 mL Oral SolutionPSN2640311d-8b88-4513-9c80-a08390b8142a4
309313citalopram 2 MG/ML Oral SolutionSCD2640311d-8b88-4513-9c80-a08390b8142a4
309313citalopram (as citalopram hydrobromide) 2 MG/ML Oral SolutionSY2640311d-8b88-4513-9c80-a08390b8142a4
309313citalopram 10 MG per 5 ML Oral SolutionSY2640311d-8b88-4513-9c80-a08390b8142a4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
17856-0564-11785605640172 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-0564-1) / 10 mL in 1 CUP, UNIT-DOSE2024-06-050000-00-00NoNoCurrent