Fluphenazine Hydrochloride (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 5 mg Tablets Bottle Label

NDC 2497913801

Fluphenazine Hydrochloride Tablets, USP

5 mg

Rx Only

100 Tablets

image description
(click image for full-size original)

PRINCIPAL DISPLAY PANEL — 10 mg Tablets Bottle Label

NDC 2497913901

Fluphenazine Hydrochloride Tablets, USP

10 mg

Rx Only

100 Tablets

image description
(click image for full-size original)

FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-136
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 1 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
Product Characteristics
Color white Score no score
Shape ROUND Size 6mm
Flavor Imprint Code T;136
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-136-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215848 08/01/2022
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-137
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 2.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MAGNESIUM STEARATE
MICROCRYSTALLINE CELLULOSE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FD&C BLUE NO. 1 ALUMINUM LAKE
FD&C BLUE NO. 2–ALUMINUM LAKE
Product Characteristics
Color BLUE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code T;137
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-137-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215848 08/01/2022
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-138
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
D&C RED NO. 27 ALUMINUM LAKE
FD&C BLUE NO. 2 ALUMINUM LAKE
Product Characteristics
Color pink Score no score
Shape ROUND Size 8mm
Flavor Imprint Code T;138
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-138-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215848 08/01/2022
FLUPHENAZINE HYDROCHLORIDE
fluphenazine hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:24979-139
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FLUPHENAZINE HYDROCHLORIDE (FLUPHENAZINE) FLUPHENAZINE HYDROCHLORIDE 10 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2910 (3 MPA.S)
LACTOSE MONOHYDRATE
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
POLYETHYLENE GLYCOL 3350
POLYVINYL ALCOHOL, UNSPECIFIED
TITANIUM DIOXIDE
TALC
FD&C YELLOW NO. 6
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 10mm
Flavor Imprint Code T;139
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:24979-139-01 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA215848 08/01/2022
Labeler — TWi Pharmaceuticals, Inc. (658402052)
Registrant — TWi Pharmaceuticals, Inc. (658402052)
Establishment
Name Address ID/FEI Operations
TWi Pharmaceuticals, Inc. Zhongli Plant 658863394 manufacture (24979-136), manufacture (24979-137), manufacture (24979-138), manufacture (24979-139), analysis (24979-136), analysis (24979-137), analysis (24979-138), analysis (24979-139), pack (24979-136), pack (24979-137), pack (24979-138), pack (24979-139)
Establishment
Name Address ID/FEI Operations
Apace Packaging LLC 361961142 pack (24979-136), pack (24979-137), pack (24979-138), pack (24979-139)
Establishment
Name Address ID/FEI Operations
BORA PHARMACEUTICAL LABORATORIES INC. 656139511 pack (24979-136), pack (24979-137), pack (24979-138), pack (24979-139)

Revised: 02/2023 TWi Pharmaceuticals, Inc.

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