FDA.reportPublic FDA data

Clomipramine Hydrochloride

Product NDC
69315-165
11-digit product format
693150165
Labeler code
69315
Product ID
69315-165_48996a58-a312-4a01-ba38-0261a18bec65
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Leading Pharma, LLC
Application
ANDA211364
Marketing category
ANDA
Marketing start
2020-03-10
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
75 mg/1
Pharmacologic classes
Tricyclic Antidepressant [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLOMIPRAMINE HYDROCHLORIDE75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2LXW0L6GWJ
Rxcui857297, 857301, 857305

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
06ad84c7-ef7f-2b11-27cb-22ae93f433b6Product name920240422

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69315-165-01Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE10010
69315-165-03Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69315-165CLOMIPRAMINE HYDROCHLORIDE CAPSULE [LEADING PHARMA, LLC]9Current NDC, Legacy NDC, 2 package rows20241212_fa0d4de8-c96e-429d-a65c-928afbf46863.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNfa0d4de8-c96e-429d-a65c-928afbf4686310
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNfa0d4de8-c96e-429d-a65c-928afbf4686310
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNfa0d4de8-c96e-429d-a65c-928afbf4686310
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDfa0d4de8-c96e-429d-a65c-928afbf4686310
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDfa0d4de8-c96e-429d-a65c-928afbf4686310
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDfa0d4de8-c96e-429d-a65c-928afbf4686310
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNff9ed80e-d692-494f-9741-a9af30fa50002
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDff9ed80e-d692-494f-9741-a9af30fa50002

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69315-165-0169315016501100 CAPSULE in 1 BOTTLE (69315-165-01) 100 capsule2020-03-100000-00-00NoNoCurrent
69315-165-036931501650330 CAPSULE in 1 BOTTLE (69315-165-03) 30 capsule2020-03-100000-00-00NoNoCurrent