FDA.reportPublic FDA data

Citalopram

Product NDC
31722-207
11-digit product format
317220207
Labeler code
31722
Product ID
31722-207_d16fcdcc-14b9-430f-9b14-900f8c2d3f84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Citalopram
Dosage form
TABLET
Route
ORAL
Labeler
Camber Pharmaceuticals
Application
ANDA077534
Marketing category
ANDA
Marketing start
2011-01-01
Marketing end
0000-00-00
Substance
CITALOPRAM HYDROBROMIDE
Active strength
20 mg/1
Pharmacologic classes
Serotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
31722-207-012025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-207-052025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-207-102025-02-19C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-207-012020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-207-052020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b
31722-207-102020-01-31C16284748780-19d75b9d0-b2fc-f424-e053-dadaa90a57ceb05c85d1-2474-4803-a0c0-585d5f764d4b

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
31722-207-01EA - Each31722-20762bf12ed-70a0-4cc9-9f68-065167dc32d812012-07-24
31722-207-05EA - Each31722-207c48cd4a1-d001-4c24-84dd-7ddcc8c5906f12012-07-24
31722-207-10EA - Each31722-20735d25347-2f1e-41e1-b5c0-7fb7bb0ab62f12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CITALOPRAM HYDROBROMIDEACTIVE INGREDIENTI1E9D14F36CITALOPRAM TABLET [READYMEDS]5
CITALOPRAMACTIVE MOIETY0DHU5B8D6VCITALOPRAM TABLET [READYMEDS]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCITALOPRAM TABLET [READYMEDS]5
COPOVIDONEINACTIVE INGREDIENTD9C330MD8BCITALOPRAM TABLET [READYMEDS]5
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48CITALOPRAM TABLET [READYMEDS]5
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675CITALOPRAM TABLET [READYMEDS]5
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6CITALOPRAM TABLET [READYMEDS]5
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XCITALOPRAM TABLET [READYMEDS]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CITALOPRAM TABLET [READYMEDS]5
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQCITALOPRAM TABLET [READYMEDS]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCITALOPRAM TABLET [READYMEDS]5

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200371citalopram 20 MG Oral TabletPSNaeea4b3f-6878-4211-a85a-b2a62772b3f85
200371citalopram 20 MG Oral TabletSCDaeea4b3f-6878-4211-a85a-b2a62772b3f85
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSYaeea4b3f-6878-4211-a85a-b2a62772b3f85
200371citalopram 20 MG Oral TabletPSN4183806e-85ed-72f2-e054-00144ff8d46c3
200371citalopram 20 MG Oral TabletSCD4183806e-85ed-72f2-e054-00144ff8d46c3
200371citalopram 20 MG (as citalopram HBr 24.99 MG) Oral TabletSY4183806e-85ed-72f2-e054-00144ff8d46c3