Drugplain

CLOMIPRAMINE HYDROCHLORIDE 25 mg/1

CLOMIPRAMINE HYDROCHLORIDE · CAPSULE · Alembic Pharmaceuticals Inc.

7 Recalls on Record
Plain English

CLOMIPRAMINE HYDROCHLORIDE is a capsule containing clomipramine hydrochloride at 25 mg/1, taken oral. Manufactured by Alembic Pharmaceuticals Inc..

Key Facts

Brand Name
CLOMIPRAMINE HYDROCHLORIDE
Generic Name
CLOMIPRAMINE HYDROCHLORIDE
NDC Code (Product)
62332-407
Manufacturer
Alembic Pharmaceuticals Inc.
Strength
25 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA211822
Marketing Start
08/05/2021

Recall History

7 Recalls on Record
Class II11/06/2020

Jubilant Cadista Pharmaceuticals, Inc.

Failed Tablet/Capsule Specification

TerminatedVoluntary: Firm initiated
Class II06/27/2025

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.

TerminatedVoluntary: Firm initiated
Class III08/23/2022

Leading Pharma, LLC

Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules

TerminatedVoluntary: Firm initiated
Class II04/10/2025

Lupin Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.

TerminatedVoluntary: Firm initiated
Class II10/22/2025

Zydus Pharmaceuticals (USA) Inc

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

OngoingVoluntary: Firm initiated
Class II10/22/2025

Zydus Pharmaceuticals (USA) Inc

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

OngoingVoluntary: Firm initiated
Class II10/22/2025

Zydus Pharmaceuticals (USA) Inc

cGMP deviations: an observed Out of Specification of Nitrosamine Drug Substance-Related Impurities (NDSRIs), N-Nitroso Desmethyl-Clomipramine, above the FDA acceptable intake limit.

OngoingVoluntary: Firm initiated

Frequently Asked Questions

What is CLOMIPRAMINE HYDROCHLORIDE used for?

CLOMIPRAMINE HYDROCHLORIDE contains CLOMIPRAMINE HYDROCHLORIDE. It is a capsule taken oral. Consult your doctor for specific uses.

Is CLOMIPRAMINE HYDROCHLORIDE a controlled substance?

CLOMIPRAMINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.

What is the generic name for CLOMIPRAMINE HYDROCHLORIDE?

The generic name for CLOMIPRAMINE HYDROCHLORIDE is CLOMIPRAMINE HYDROCHLORIDE. There are 4 other brand versions of CLOMIPRAMINE HYDROCHLORIDE.

What is the NDC code for CLOMIPRAMINE HYDROCHLORIDE 25 mg/1?

The NDC (National Drug Code) for CLOMIPRAMINE HYDROCHLORIDE 25 mg/1 is 62332-407, listed by Alembic Pharmaceuticals Inc..

Product NDC

62332-407

Package NDC

62332-407-30

Other Clomipramine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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