CLOMIPRAMINE HYDROCHLORIDE

Product NDC
42571-343
11-digit product format
425710343
Labeler code
42571
Product ID
42571-343_35016ce5-40f8-fce9-e063-6394a90af976
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLOMIPRAMINE HYDROCHLORIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA213219
Marketing category
ANDA
Marketing start
2020-09-01
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
42571-343-01CLOMIPRAMINE HYDROCHLORIDE100 in 1 BOTTLECAPSULE1007
42571-343-30CLOMIPRAMINE HYDROCHLORIDE30 in 1 BOTTLECAPSULE307
42571-343-90CLOMIPRAMINE HYDROCHLORIDE90 in 1 BOTTLECAPSULE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-343CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE) CAPSULE [MICRO LABS LIMITED]7Current NDC, Legacy NDC, 3 package rows20250515_0bbee292-0fba-4606-9c8e-4723742682c0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN0bbee292-0fba-4606-9c8e-4723742682c07
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN0bbee292-0fba-4606-9c8e-4723742682c07
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN0bbee292-0fba-4606-9c8e-4723742682c07
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD0bbee292-0fba-4606-9c8e-4723742682c07
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD0bbee292-0fba-4606-9c8e-4723742682c07
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD0bbee292-0fba-4606-9c8e-4723742682c07

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-343-0142571034301100 CAPSULE in 1 BOTTLE (42571-343-01) 100 capsule2020-09-010000-00-00NoNoCurrent
42571-343-304257103433030 CAPSULE in 1 BOTTLE (42571-343-30) 30 capsule2020-09-010000-00-00NoNoCurrent
42571-343-904257103439090 CAPSULE in 1 BOTTLE (42571-343-90) 90 capsule2020-09-010000-00-00NoNoCurrent