Clomipramine hydrochloride

Product NDC
27241-210
11-digit product format
272410210
Labeler code
27241
Product ID
27241-210_a0384dc3-9ab1-4632-bbb8-4e84e0a6a2e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clomipramine hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA213897
Marketing category
ANDA
Marketing start
2020-12-23
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
27241-210-01Clomipramine hydrochloride100 in 1 BOTTLECAPSULE1003
27241-210-30Clomipramine hydrochloride30 in 1 BOTTLECAPSULE303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-210-01EA - Each27241-2100ed7a852-15f4-46e4-aad6-327051ef56b912021-02-05
27241-210-30EA - Each27241-210550940e1-a598-463d-96ab-5e73412ca2c312021-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-210CLOMIPRAMINE HYDROCHLORIDE CAPSULE [AJANTA PHARMA USA INC.]3Current NDC, Legacy NDC, 2 package rows20211126_0bf3c4f3-cf70-490d-89d8-9fb84962489e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857297clomiPRAMINE HCl 25 MG Oral CapsulePSN0bf3c4f3-cf70-490d-89d8-9fb84962489e3
857301clomiPRAMINE HCl 50 MG Oral CapsulePSN0bf3c4f3-cf70-490d-89d8-9fb84962489e3
857305clomiPRAMINE HCl 75 MG Oral CapsulePSN0bf3c4f3-cf70-490d-89d8-9fb84962489e3
857297clomipramine hydrochloride 25 MG Oral CapsuleSCD0bf3c4f3-cf70-490d-89d8-9fb84962489e3
857301clomipramine hydrochloride 50 MG Oral CapsuleSCD0bf3c4f3-cf70-490d-89d8-9fb84962489e3
857305clomipramine hydrochloride 75 MG Oral CapsuleSCD0bf3c4f3-cf70-490d-89d8-9fb84962489e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-210-0127241021001100 CAPSULE in 1 BOTTLE (27241-210-01) 100 capsule2020-12-230000-00-00NoNoCurrent
27241-210-302724102103030 CAPSULE in 1 BOTTLE (27241-210-30) 30 capsule2020-12-230000-00-00NoNoCurrent