MedPath

Chlorpromazine

Generic Name
Chlorpromazine
Drug Type
Small Molecule
Chemical Formula
C17H19ClN2S
CAS Number
50-53-3
Unique Ingredient Identifier
U42B7VYA4P

Overview

The prototypical phenothiazine antipsychotic drug. Like the other drugs in this class, chlorpromazine's antipsychotic actions are thought to be due to long-term adaptation by the brain to blocking dopamine receptors. Chlorpromazine has several other actions and therapeutic uses, including as an antiemetic and in the treatment of intractable hiccup.

Indication

For the treatment of schizophrenia; to control nausea and vomiting; for relief of restlessness and apprehension before surgery; for acute intermittent porphyria; as an adjunct in the treatment of tetanus; to control the manifestations of the manic type of manic-depressive illness; for relief of intractable hiccups; for the treatment of severe behavioral problems in children (1 to 12 years of age) marked by combativeness and/or explosive hyperexcitable behavior (out of proportion to immediate provocations), and in the short-term treatment of hyperactive children who show excessive motor activity with accompanying conduct disorders consisting of some or all of the following symptoms: impulsivity, difficulty sustaining attention, aggressivity, mood lability, and poor frustration tolerance.

Associated Conditions

  • Acute Intermittent Porphyria (AIP)
  • Apprehension
  • Defiant Disorder, Oppositional
  • Intractable hiccups
  • Mania
  • Nausea and vomiting
  • Restlessness
  • Schizophrenia
  • Tetanus
  • Severe behavioural problems
  • Short term Hyperactivity

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Zydus Pharmaceuticals USA Inc.
70710-1850
INTRAMUSCULAR
25 mg in 1 mL
3/31/2023
State of Florida DOH Central Pharmacy
53808-0924
ORAL
25 mg in 1 1
5/21/2010
Alembic Pharmaceuticals Limited
46708-737
ORAL
50 mg in 1 1
7/25/2023
Zydus Pharmaceuticals (USA) Inc.
70710-1132
ORAL
100 mg in 1 1
9/18/2023
Zydus Pharmaceuticals USA Inc.
70710-1849
INTRAMUSCULAR
25 mg in 1 mL
3/31/2023
Northstar Rx LLC
16714-049
ORAL
50 mg in 1 1
9/18/2023
Chartwell RX, LLC
62135-423
ORAL
100 mg in 1 1
10/5/2023
Northstar Rx LLC
16714-050
ORAL
100 mg in 1 1
9/18/2023
Lannett Company, Inc.
0527-2965
ORAL
200 mg in 1 1
2/19/2020
Upsher-Smith Laboratories, LLC
0832-6018
ORAL
25 mg in 1 1
8/11/2021

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
CHLORPROMAZINE 100 TABLET 100 mg
SIN07528P
TABLET, FILM COATED
100 mg
10/26/1993
CHLORPROMAZINE 25 TABLET 25 mg
SIN07195P
TABLET, FILM COATED
25 mg
10/12/1992
LARGO TABLETS 25 mg
SIN00095P
TABLET, FILM COATED
25 mg
3/16/1988
CHLORPROMAZINE HYDROCHLORIDE TABLET 50 mg
SIN06832P
TABLET, FILM COATED
50 mg
2/15/1992
LARGO TABLET 100 mg
SIN00096P
TABLET, FILM COATED
100 mg
3/16/1988

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Health Canada Drug Approvals

Approved Product
Company
DIN
Dosage Form
Strength
Market Date
CHLORPROMAZINE TABLETS B.P. 50MG
clonmel healthcare limited
01985450
Tablet - Oral
50 MG / TAB
12/31/1992
CHLORPROMANYL 40 DROPS SYR 44.5MG/ML
technilab pharma inc.
00690805
Syrup - Oral
44.5 MG / ML
12/31/1986
CHLORPROM TAB 25MG
icn canada ltd.
00295086
Tablet - Oral
27.9 MG / TAB
12/31/1974
CHLORPROMAZINE TABLETS B.P. 25MG
clonmel healthcare limited
01985434
Tablet - Oral
25 MG / TAB
12/31/1992
CHLORPROM TAB 100MG
icn canada ltd.
00271128
Tablet - Oral
111.6 MG / TAB
12/31/1962
APO CHLORPROMAZINE
00312703
Tablet - Oral
27.9 MG
12/31/1976
NOVO-CHLORPROMAZINE 200MG
novopharm limited
00021342
Tablet - Oral
223.2 MG
12/31/1970
LARGACTIL SUP 100MG
sanofi-aventis canada inc
01930001
Suppository - Rectal
100 MG
12/31/1952
APO CHLORPROMAZINE
00312673
Tablet - Oral
55.7 MG
12/31/1976
CHLORPROMAZINE TABLETS B.P. 100MG
clonmel healthcare limited
01985442
Tablet - Oral
100 MG / TAB
12/31/1992

CIMA AEMPS Drug Approvals

Approved Product
Company
Registration Number
Pharmaceutical Form
Prescription Type
Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product
Company
License Number
Dosage Form
Strength
Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product
Company
Registration Number
Dosage Form
Strength
Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name
MA Holder
MA Number
Pharmaceutical Form
Active Ingredient
Authorization Date
No UK EMC drug information found for this drug.

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