Clomipramine Hydrochloride

Product NDC
68180-493
11-digit product format
681800493
Labeler code
68180
Product ID
68180-493_7e89336a-0de0-42d6-af70-26345940b81d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride Capsules
Dosage form
CAPSULE
Route
ORAL
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA209294
Marketing category
ANDA
Marketing start
2019-02-04
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
68180-493-01Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE10013
68180-493-06Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE3013
68180-493-07Clomipramine Hydrochloride60 in 1 BOTTLECAPSULE6013
68180-493-09Clomipramine Hydrochloride90 in 1 BOTTLECAPSULE9013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68180-493-01EA - Each68180-493ff7e398e-3d0b-4015-a992-924217bc43ea12019-02-13
68180-493-06EA - Each68180-49372d5df1d-4909-4167-b54e-d482910073c812019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68180-493CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES) CAPSULE [LUPIN PHARMACEUTICALS, INC.]13Current NDC, Legacy NDC, 4 package rows20241219_ebad19b5-e5dd-4f77-ab97-d20ce0f24cb9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNebad19b5-e5dd-4f77-ab97-d20ce0f24cb913
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNebad19b5-e5dd-4f77-ab97-d20ce0f24cb913
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNebad19b5-e5dd-4f77-ab97-d20ce0f24cb913
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDebad19b5-e5dd-4f77-ab97-d20ce0f24cb913
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDebad19b5-e5dd-4f77-ab97-d20ce0f24cb913
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDebad19b5-e5dd-4f77-ab97-d20ce0f24cb913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68180-493-0168180049301100 CAPSULE in 1 BOTTLE (68180-493-01) 100 capsule2019-02-040000-00-00NoNoCurrent
68180-493-066818004930630 CAPSULE in 1 BOTTLE (68180-493-06) 30 capsule2019-02-040000-00-00NoNoCurrent
68180-493-076818004930760 CAPSULE in 1 BOTTLE (68180-493-07) 60 capsule2019-02-040000-00-00NoNoCurrent
68180-493-096818004930990 CAPSULE in 1 BOTTLE (68180-493-09) 90 capsule2019-02-040000-00-00NoNoCurrent