Chlorpromazine Hydrochloride

CHLORPROMAZINE HYDROCHLORIDE- chlorpromazine hydrochloride tablet, film coated
Cadila Healthcare Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 70771-1506-1

ChlorproMAZINE Hydrochloride Tablets, USP

10 mg

100 Tablets

Rx only

label
(click image for full-size original)

NDC 70771-1507-1

ChlorproMAZINE Hydrochloride Tablets, USP

25 mg

100 Tablets

Rx only

label
(click image for full-size original)

NDC 70771-1508-1

ChlorproMAZINE Hydrochloride Tablets, USP

50 mg

100 Tablets

Rx only

label
(click image for full-size original)

NDC 70771-1509-1

ChlorproMAZINE Hydrochloride Tablets, USP

100 mg

100 Tablets

Rx only

label
(click image for full-size original)

NDC 70771-1510-1

ChlorproMAZINE Hydrochloride Tablets, USP

200 mg

100 Tablets

Rx only

label
(click image for full-size original)
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1506
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 6mm
Flavor Imprint Code 11;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1506-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1506-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1506-2)
2 NDC:70771-1506-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1506-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213368 01/27/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1507
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 8mm
Flavor Imprint Code 11;30
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1507-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1507-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1507-2)
2 NDC:70771-1507-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1507-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213368 01/27/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1508
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 50 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 7mm
Flavor Imprint Code 11;31
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1508-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1508-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1508-2)
2 NDC:70771-1508-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1508-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213368 01/27/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1509
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 10mm
Flavor Imprint Code 11;32
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1509-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1509-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1509-2)
2 NDC:70771-1509-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1509-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213368 01/27/2020
CHLORPROMAZINE HYDROCHLORIDE
chlorpromazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70771-1510
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORPROMAZINE HYDROCHLORIDE (CHLORPROMAZINE) CHLORPROMAZINE HYDROCHLORIDE 200 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM SULFATE DIHYDRATE
CROSCARMELLOSE SODIUM
FD&C BLUE NO. 2
FD&C YELLOW NO. 6
HYPROMELLOSE 2910 (5 MPA.S)
HYPROMELLOSE 2910 (6 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE 102
POLYETHYLENE GLYCOL 400
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
TALC
TITANIUM DIOXIDE
Product Characteristics
Color BROWN Score no score
Shape ROUND Size 12mm
Flavor Imprint Code 11;33
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70771-1510-1 100 TABLET, FILM COATED in 1 BOTTLE None
2 NDC:70771-1510-4 10 BLISTER PACK in 1 CARTON contains a BLISTER PACK (70771-1510-2)
2 NDC:70771-1510-2 10 TABLET, FILM COATED in 1 BLISTER PACK This package is contained within the CARTON (70771-1510-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213368 01/27/2020
Labeler — Cadila Healthcare Limited (918596198)
Registrant — Cadila Healthcare Limited (677605858)
Establishment
Name Address ID/FEI Operations
Cadila Healthcare Limited 677605858 ANALYSIS (70771-1506), ANALYSIS (70771-1507), ANALYSIS (70771-1508), ANALYSIS (70771-1509), ANALYSIS (70771-1510), MANUFACTURE (70771-1506), MANUFACTURE (70771-1507), MANUFACTURE (70771-1508), MANUFACTURE (70771-1509), MANUFACTURE (70771-1510)

Revised: 05/2020 Cadila Healthcare Limited

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