Benzonatate (Page 2 of 2)

BENZONATATE

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BENZONATATE benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-029(NDC:67877-573)
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
WATER
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 105
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-029-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-029-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040627 03/22/2017
BENZONATATE benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:63739-124(NDC:67877-575)
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
WATER
METHYLPARABEN
PROPYLPARABEN
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 19mm
Flavor Imprint Code 106
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:63739-124-10 10 BLISTER PACK in 1 BOX, UNIT-DOSE contains a BLISTER PACK
1 10 CAPSULE in 1 BLISTER PACK This package is contained within the BOX, UNIT-DOSE (63739-124-10)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040749 03/22/2017 04/30/2019
Labeler — McKesson Corporation dba SKY Packaging (140529962)
Establishment
Name Address ID/FEI Operations
Legacy Pharmaceutical Packaging, LLC 143213275 repack (63739-029), repack (63739-124), relabel (63739-029), relabel (63739-124)

Revised: 12/2023 McKesson Corporation dba SKY Packaging

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