Clomipramine Hydrochloride

Product NDC
63629-1111
11-digit product format
636291111
Labeler code
63629
Product ID
63629-1111_428d259f-6ef6-4086-b6d3-c32dac048044
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211767
Marketing category
ANDA
Marketing start
2020-03-01
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
Rxcui857305

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
63629-1111-1Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE1007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1111-1EA - Each63629-111196e75372-d1a1-41cd-bedd-33fa708d896412020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1111CLOMIPRAMINE HYDROCHLORIDE CAPSULE [BRYANT RANCH PREPACK]7Current NDC, Legacy NDC, 1 package rows20230224_bbf275df-2fe0-443c-99ca-2298721441dc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNbbf275df-2fe0-443c-99ca-2298721441dc7
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDbbf275df-2fe0-443c-99ca-2298721441dc7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1111-163629111101100 CAPSULE in 1 BOTTLE (63629-1111-1) 100 capsule2020-03-010000-00-00NoNoCurrent