CLOMIPRAMINE HYDROCHLORIDE 75 mg/1
clomipramine hydrochloride · CAPSULE · SpecGx LLC
CLOMIPRAMINE HYDROCHLORIDE is a capsule containing clomipramine hydrochloride at 75 mg/1, taken oral. Manufactured by SpecGx LLC.
Key Facts
- Brand Name
- CLOMIPRAMINE HYDROCHLORIDE
- Generic Name
- clomipramine hydrochloride
- NDC Code (Product)
0406-8808- Manufacturer
- SpecGx LLC
- Strength
- 75 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- NDA019906
- Marketing Start
- 06/01/2015
Recall History
Jubilant Cadista Pharmaceuticals, Inc.
Failed Tablet/Capsule Specification
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.
Leading Pharma, LLC
Superpotent Drug: Assay value found to be 110.6% in Chlomipramine Hydrocholoride capsules
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.
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.
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.
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.
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 75 mg/1?
The NDC (National Drug Code) for CLOMIPRAMINE HYDROCHLORIDE 75 mg/1 is 0406-8808, listed by SpecGx LLC.