BENZONATATE (Page 2 of 2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL — 200 mg

NDC 62332-427 -31
Benzonatate
Capsules, USP
200 mg
Rx only
100 Capsules
Alembic

100 capsules
(click image for full-size original)

BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-426
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, UNSPECIFIED
GLYCERIN
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
Product Characteristics
Color YELLOW Score no score
Shape OVAL Size 9mm
Flavor Imprint Code A5
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-426-31 100 CAPSULE in 1 BOTTLE None
2 NDC:62332-426-71 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040682 05/01/2018
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:62332-427
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
D&C YELLOW NO. 10
GELATIN, UNSPECIFIED
GLYCERIN
METHYLPARABEN SODIUM
PROPYLPARABEN SODIUM
Product Characteristics
Color YELLOW Score no score
Shape CAPSULE Size 16mm
Flavor Imprint Code A6
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:62332-427-31 100 CAPSULE in 1 BOTTLE None
2 NDC:62332-427-71 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040682 05/01/2018
Labeler — Alembic Pharmaceuticals Inc. (079288842)
Establishment
Name Address ID/FEI Operations
Swiss Caps AG 481784895 MANUFACTURE (62332-426), MANUFACTURE (62332-427)

Revised: 10/2021 Alembic Pharmaceuticals Inc.

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