Benzonatate (Page 2 of 2)

Principal Display Panel

Benzonatate Capsules, USP 100 mg

Rx only 100 Capsules

NDC 11788-028-01

ben100
(click image for full-size original)

Benzonatate Capsules, USP 150mg

Rx only 100 Capsules

NDC 11788-029-01

ben150
(click image for full-size original)

Benzonatate Capsules, USP 200mg

NDC 11788-027-01

Rx only 100 Capsules

ben200
(click image for full-size original)
BENZONATATE benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-028
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
WATER
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 9mm
Flavor Imprint Code Logo;28
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-028-01 100 CAPSULE in 1 BOTTLE None
2 NDC:11788-028-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210562 03/14/2019
BENZONATATE benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-029
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BENZONATATE (BENZONATATE) BENZONATATE 150 mg
Inactive Ingredients
Ingredient Name Strength
D&C YELLOW NO. 10
GELATIN
GLYCERIN
WATER
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 10mm
Flavor Imprint Code Logo;29
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-029-01 100 CAPSULE in 1 BOTTLE None
2 NDC:11788-029-05 500 CAPSULE in 1 PACKAGE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210562 03/14/2019
BENZONATATE benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:11788-027
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
GLYCERIN
WATER
METHYLPARABEN
PROPYLPARABEN
PROPYLENE GLYCOL
SHELLAC
TITANIUM DIOXIDE
Product Characteristics
Color yellow Score no score
Shape CAPSULE Size 11mm
Flavor Imprint Code Logo;27
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11788-027-01 100 CAPSULE in 1 BOTTLE None
2 NDC:11788-027-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA210562 03/14/2019
Labeler — AiPing Pharmaceutical, Inc. (079674526)
Establishment
Name Address ID/FEI Operations
Anshi Pharmaceutical (Zhongshan) Inc. 528101821 manufacture (11788-028), manufacture (11788-029), manufacture (11788-027)

Revised: 10/2022 AiPing Pharmaceutical, Inc.

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