Clomipramine Hydrochloride

Product NDC
59651-381
11-digit product format
596510381
Labeler code
59651
Product ID
59651-381_7d11010e-cf0f-4315-aced-7927a486a1ef
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216440
Marketing category
ANDA
Marketing start
2023-03-20
Substance
CLOMIPRAMINE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
59651-381-01Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE1001
59651-381-30Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE301
59651-381-90Clomipramine Hydrochloride90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-381-01EA - Each59651-38198b86dcb-4d54-440a-a4ef-16564ca647c512023-06-06
59651-381-30EA - Each59651-38199bf0563-c16f-407b-9227-1e8bcce2f43e12023-06-06
59651-381-90EA - Each59651-38199f3f434-2138-47fd-a313-272cd11d502c12023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-381CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20230408_7d11010e-cf0f-4315-aced-7927a486a1ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN7d11010e-cf0f-4315-aced-7927a486a1ef1
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN7d11010e-cf0f-4315-aced-7927a486a1ef1
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN7d11010e-cf0f-4315-aced-7927a486a1ef1
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD7d11010e-cf0f-4315-aced-7927a486a1ef1
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD7d11010e-cf0f-4315-aced-7927a486a1ef1
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD7d11010e-cf0f-4315-aced-7927a486a1ef1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-381-0159651038101100 CAPSULE in 1 BOTTLE (59651-381-01) 100 capsule2023-03-20NoNoCurrent
59651-381-22596510381222000 CAPSULE in 1 BAG (59651-381-22)2000 capsule20-MAR-23Current
59651-381-305965103813030 CAPSULE in 1 BOTTLE (59651-381-30) 30 capsule2023-03-20NoNoCurrent
59651-381-905965103819090 CAPSULE in 1 BOTTLE (59651-381-90) 90 capsule2023-03-20NoNoCurrent