NDC 16714-047
Chlorpromazine hydrochloride 10 mg tablet, film coated
On the label: Northstar Rx LLC..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Lifesciences Limited | Solan, India | Makes it and tests it | No problems foundMar 9, 2020 · 6 inspections |
Recalls
- Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot#: Z403011, Exp Date 30-04-26; Z407335, Exp Date 30-11-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305062, exp 31-08-25; Z306324, Exp Date 30-11-25; Z401151, Z401152, Exp Date 28-02-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z306326, Exp Date 30-11-25; Z401155, Exp Date 28-02-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305456, Exp Date 31-10-25; Z401156, Exp Date 28-02-26; Z407306, Exp Date 30-11-26 - Sep 3, 2025 · Class II · Zydus Pharmaceuticals (USA) Inc
CGMP Deviations: presence of N-Nitroso Desmethyl Chlorpromazine above the recommended acceptable intake limit
Lots: Lot #: Z305085, Exp Date 30-09-25; Z401166, Z401167, Exp Date 28-02-26
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Chlorpromazine: every company that makes it
- Form
- tablet, film coated, oral
- Strength
- 10 mg
- Approval
- ANDA ANDA213368
- On the market since
- May 11, 2020
- Package NDCs
16714-047-01- Official label
- DailyMed (National Library of Medicine), updated Aug 26, 2026
Got it by mail or from a pharmacy you don't know? Look the pharmacy up on Who Filled My Rx?