FDA.reportPublic FDA data

Clomipramine Hydrochloride

Product NDC
70756-406
11-digit product format
707560406
Labeler code
70756
Product ID
70756-406_0e501982-ad23-470b-bf7a-5af413644d25
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Lifestar Pharma LLC
Application
ANDA211767
Marketing category
ANDA
Marketing start
2020-03-01
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
70756-406-11Clomipramine Hydrochloride100 in 1 BOTTLECAPSULE1009
70756-406-30Clomipramine Hydrochloride30 in 1 BOTTLECAPSULE309

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70756-406-11EA - Each70756-406b23d890d-b33e-4cde-8dcb-3346a68bd15212020-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70756-406CLOMIPRAMINE HYDROCHLORIDE CAPSULE [LIFESTAR PHARMA LLC]9Current NDC, Legacy NDC, 2 package rows20231129_a8dc192b-3334-4ca4-8862-3f320014dfb0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSNa8dc192b-3334-4ca4-8862-3f320014dfb09
857301clomiPRAMINE HCl 50 MG Oral CapsulePSNa8dc192b-3334-4ca4-8862-3f320014dfb09
857305clomiPRAMINE HCl 75 MG Oral CapsulePSNa8dc192b-3334-4ca4-8862-3f320014dfb09
857297clomipramine hydrochloride 25 MG Oral CapsuleSCDa8dc192b-3334-4ca4-8862-3f320014dfb09
857301clomipramine hydrochloride 50 MG Oral CapsuleSCDa8dc192b-3334-4ca4-8862-3f320014dfb09
857305clomipramine hydrochloride 75 MG Oral CapsuleSCDa8dc192b-3334-4ca4-8862-3f320014dfb09

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70756-406-1170756040611100 CAPSULE in 1 BOTTLE (70756-406-11) 100 capsule2020-03-010000-00-00NoNoCurrent
70756-406-307075604063030 CAPSULE in 1 BOTTLE (70756-406-30) 30 capsule2020-03-010000-00-00NoNoCurrent