CHLORPROMAZINE HYDROCHLORIDE 100 mg/1
CHLORPROMAZINE HYDROCHLORIDE · TABLET, FILM COATED · Amneal Pharmaceuticals NY LLC
CHLORPROMAZINE HYDROCHLORIDE is a tablet, film coated containing chlorpromazine hydrochloride at 100 mg/1, taken oral. Manufactured by Amneal Pharmaceuticals NY LLC.
Key Facts
- Brand Name
- CHLORPROMAZINE HYDROCHLORIDE
- Generic Name
- CHLORPROMAZINE HYDROCHLORIDE
- NDC Code (Product)
69238-1060- Manufacturer
- Amneal Pharmaceuticals NY LLC
- Strength
- 100 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA209755
- Marketing Start
- 09/12/2018
Recall History
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Glenmark Pharmaceuticals Inc., USA
CGMP Deviations: N-Nitroso-Desmethyl Chlorpromazine impurity (NNDCI) were found to be failing per current FDA recommended limit.
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Amerisource Health Services LLC
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Frequently Asked Questions
What is CHLORPROMAZINE HYDROCHLORIDE used for?
CHLORPROMAZINE HYDROCHLORIDE contains CHLORPROMAZINE HYDROCHLORIDE. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is CHLORPROMAZINE HYDROCHLORIDE a controlled substance?
CHLORPROMAZINE HYDROCHLORIDE is not classified as a controlled substance by the DEA.
What is the generic name for CHLORPROMAZINE HYDROCHLORIDE?
The generic name for CHLORPROMAZINE HYDROCHLORIDE is CHLORPROMAZINE HYDROCHLORIDE. There are 11 other brand versions of CHLORPROMAZINE HYDROCHLORIDE.
What is the NDC code for CHLORPROMAZINE HYDROCHLORIDE 100 mg/1?
The NDC (National Drug Code) for CHLORPROMAZINE HYDROCHLORIDE 100 mg/1 is 69238-1060, listed by Amneal Pharmaceuticals NY LLC.
Other CHLORPROMAZINE HYDROCHLORIDE Dosages
Other Chlorpromazine Brands
See all →- Chlorpromazine hydrochloride25 mg/mL73043-049
- Chlorpromazine hydrochloride25 mg/mL0641-1398
- Chlorpromazine Hydrochloride25 mg/10832-6018
- Chlorpromazine Hydrochloride100 mg/10832-6020
- Chlorpromazine Hydrochloride200 mg/151407-438
- chlorpromazine hydrochloride10 mg/162135-420
- Chlorpromazine hydrochloride100 mg/170771-1509
- Chlorpromazine Hydrochloride30 mg/mL71656-102
- Chlorpromazine Hydrochloride200 mg/10527-2965
- Chlorpromazine Hydrochloride100 mg/mL0781-4028
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)