FDA.reportPublic FDA data

CLOMIPRAMINE HYDROCHLORIDE

Product NDC
51672-4013
11-digit product format
516724013
Labeler code
51672
Product ID
51672-4013_34699b9e-d070-64b2-e063-6294a90a0f6d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA074694
Marketing category
ANDA
Marketing start
1996-12-31
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
51672-4013-1CLOMIPRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE10012
51672-4013-4CLOMIPRAMINE HYDROCHLORIDE60 in 1 BOTTLECAPSULE6012
51672-4013-5CLOMIPRAMINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE9012
51672-4013-6CLOMIPRAMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4013-1EA - Each51672-40137fb01f4b-0ae0-46fc-8cac-b667016c106d12023-09-05
51672-4013-5EA - Each51672-4013a3d56123-aec0-4fbf-9e36-bd142fda431a12012-07-24
51672-4013-6EA - Each51672-4013cfb8116b-083b-45d1-b331-212bb0d77f4212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clomipramine HydrochlorideACTIVE INGREDIENT2LXW0L6GWJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
ClomipramineACTIVE MOIETYNUV44L116DCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Blue No. 2INACTIVE INGREDIENTL06K8R7DQKCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
FD&C Red No. 3INACTIVE INGREDIENTPN2ZH5LOQYCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferric Oxide YellowINACTIVE INGREDIENTEX438O2MRTCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Ferrosoferric OxideINACTIVE INGREDIENTXM0M87F357CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
GelatinINACTIVE INGREDIENT2G86QN327LCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Magnesium StearateINACTIVE INGREDIENT70097M6I30CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Silicon DioxideINACTIVE INGREDIENTETJ7Z6XBU4CLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Starch, CornINACTIVE INGREDIENTO8232NY3SJCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4
Titanium DioxideINACTIVE INGREDIENT15FIX9V2JPCLOMIPRAMINE HYDROCHLORIDE CAPSULE [TARO PHARMACEUTICALS U.S.A., INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4013CLOMIPRAMINE HYDROCHLORIDE CAPSULE [SUN PHARMACEUTICAL INDUSTRIES, INC.]12Current NDC, Legacy NDC, 4 package rows20250507_db752dbd-be41-4cdd-8a13-ed1ff9ef7461.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDdb752dbd-be41-4cdd-8a13-ed1ff9ef746112
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNfa2eb38c-b155-0d53-e053-6294a90a1d293
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNfa2eb38c-b155-0d53-e053-6294a90a1d293
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNfa2eb38c-b155-0d53-e053-6294a90a1d293
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDfa2eb38c-b155-0d53-e053-6294a90a1d293
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDfa2eb38c-b155-0d53-e053-6294a90a1d293
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDfa2eb38c-b155-0d53-e053-6294a90a1d293

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4013-151672401301100 CAPSULE in 1 BOTTLE (51672-4013-1) 100 capsule1996-12-310000-00-00NoNoCurrent
51672-4013-45167240130460 CAPSULE in 1 BOTTLE (51672-4013-4) 60 capsule1996-12-310000-00-00NoNoCurrent
51672-4013-55167240130590 CAPSULE in 1 BOTTLE (51672-4013-5) 90 capsule1996-12-310000-00-00NoNoCurrent
51672-4013-65167240130630 CAPSULE in 1 BOTTLE (51672-4013-6) 30 capsule1996-12-310000-00-00NoNoCurrent