FDA.reportPublic FDA data

Citalopram

Product NDC
68999-540
11-digit product format
689990540
Labeler code
68999
Product ID
68999-540_484c3f19-d5f7-3e00-e063-6394a90a1938
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
SOLUTION
Route
ORAL
Labeler
Chartwell Governmental & Specialty RX, LLC.
Application
ANDA077629
Marketing category
ANDA
Marketing start
2006-06-14
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Citalopram
Listing expiration
2027-12-31

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
475812f9-1b2c-4cb0-9e72-1e52f935ae6fProduct name120221114
0b05d650-9b7b-4b36-a6f4-1a850d5a2e64Product name120151228
e61ea6cb-0b08-40a9-a984-7b23201c7aa2Product name120151222
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68999-540-10Citalopram10 mL in 1 CUPSOLUTION101
68999-540-24Citalopram10 in 1 TRAYSOLUTION101
68999-540-24Citalopram2 in 1 BOXSOLUTION21

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68999-540-10ML - Milliliter68999-5400493c23d-7dea-40ea-b6b8-331fa188080512026-03-17
68999-540-24ML - Milliliter68999-5406a5154b3-c568-4f9a-ab0f-79ef75031afd12026-03-17

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309313citalopram 10 MG in 5 mL Oral SolutionPSN3114274f-d81f-4b1f-8f17-35db9eee2ffe1
309313citalopram 2 MG/ML Oral SolutionSCD3114274f-d81f-4b1f-8f17-35db9eee2ffe1
309313citalopram (as citalopram hydrobromide) 2 MG/ML Oral SolutionSY3114274f-d81f-4b1f-8f17-35db9eee2ffe1
309313citalopram 10 MG per 5 ML Oral SolutionSY3114274f-d81f-4b1f-8f17-35db9eee2ffe1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68999-540-106899905401010 mL in 1 CUP10 mlHistorical
68999-540-24689990540242 TRAY in 1 BOX (68999-540-24) / 10 CUP in 1 TRAY / 10 mL in 1 CUP (68999-540-10) 2 tray2026-01-13NoNoHistorical