Benzonatate (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-712
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZONATATE (BENZONATATE) BENZONATATE 100 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
GELATIN
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
Product Characteristics
Color YELLOW (Yellow) Score no score
Shape OVAL (oval shaped) Size 9mm
Flavor Imprint Code 705
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-712-06 100 CAPSULE in 1 CONTAINER None
2 NDC:64380-712-07 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091133 12/10/2016
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:64380-713
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZONATATE (BENZONATATE) BENZONATATE 200 mg
Inactive Ingredients
Ingredient Name Strength
METHYLPARABEN
PROPYLPARABEN
D&C YELLOW NO. 10
GLYCERIN
GELATIN
Product Characteristics
Color YELLOW (Yellow) Score no score
Shape OVAL (oval shaped) Size 10mm
Flavor Imprint Code 704
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:64380-713-06 100 CAPSULE in 1 CONTAINER None
2 NDC:64380-713-07 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA091133 12/10/2016
Labeler — Strides Pharma Science Limited (650738743)

Revised: 12/2020 Strides Pharma Science Limited

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