FDA.reportPublic FDA data

CLOMIPRAMINE HYDROCHLORIDE

Product NDC
0406-8807
11-digit product format
004068807
Labeler code
0406
Product ID
0406-8807_f7da2c91-cd58-46c3-b716-846a454cfb07
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
clomipramine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
SpecGx LLC
Application
NDA019906
Marketing category
NDA
Marketing start
2015-06-01
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
50 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 HYDROCHLORIDE50 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
0406-8807-01CLOMIPRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE10015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0406-8807-01EA - Each0406-880741b08e2f-718d-4bd8-a08e-8febb4867bfb12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLOMIPRAMINE HYDROCHLORIDEACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
CLOMIPRAMINEACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
GELATININACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [MALLINCKRODT, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0406-8807CLOMIPRAMINE HYDROCHLORIDE CAPSULE [SPECGX LLC]15Current NDC, Legacy NDC, 1 package rows20241128_d7cee3fa-d05c-4702-8f75-f446627bdb49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNd7cee3fa-d05c-4702-8f75-f446627bdb4915
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNd7cee3fa-d05c-4702-8f75-f446627bdb4915
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNd7cee3fa-d05c-4702-8f75-f446627bdb4915
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDd7cee3fa-d05c-4702-8f75-f446627bdb4915
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDd7cee3fa-d05c-4702-8f75-f446627bdb4915
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDd7cee3fa-d05c-4702-8f75-f446627bdb4915

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0406-8807-0100406880701100 CAPSULE in 1 BOTTLE (0406-8807-01) 100 capsule2015-06-010000-00-00NoNoCurrent