MedPath

CLOMIPRAMINE HYDROCHLORIDE

ClomiPRAMINEHydrochlorideCapsules USP

Approved
Approval ID

33c772f8-08f0-4f99-8fbd-4de48ad82d89

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 6, 2012

Manufacturers
FDA

Physicians Total Care, Inc.

DUNS: 194123980

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Clomipramine Hydrochloride

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code54868-4023
Application NumberANDA074694
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clomipramine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 6, 2012
FDA Product Classification

INGREDIENTS (7)

Clomipramine HydrochlorideActive
Quantity: 50 mg in 1 1
Code: 2LXW0L6GWJ
Classification: ACTIB
GelatinInactive
Code: 2G86QN327L
Classification: IACT
Magnesium StearateInactive
Code: 70097M6I30
Classification: IACT
Ferric Oxide YellowInactive
Code: EX438O2MRT
Classification: IACT
Starch, CornInactive
Code: O8232NY3SJ
Classification: IACT
Silicon DioxideInactive
Code: ETJ7Z6XBU4
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

CLOMIPRAMINE HYDROCHLORIDE - FDA Drug Approval Details