Benzonatate

BENZONATATE — benzonatate capsule
Zydus Lifesciences Limited

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 65841-614-01 in bottle of 100 capsules

Benzonatate Capsules USP, 100 mg

Rx only

100 capsules

Benzonatate Capsules
(click image for full-size original)

NDC 65841-843-01 in bottle of 100 capsules

Benzonatate Capsules USP, 200 mg

Rx only

100 capsules

Benzonatate Capsules
(click image for full-size original)
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-614
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
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
SORBITOL
WATER
GELATIN
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape ROUND (ROUND) Size 3mm
Flavor Imprint Code Z
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-614-01 100 CAPSULE in 1 BOTTLE None
2 NDC:65841-614-05 500 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040597 09/04/2007
BENZONATATE
benzonatate capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-843
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
GLYCERIN
METHYLPARABEN
PROPYLPARABEN
SORBITOL
WATER
GELATIN
Product Characteristics
Color YELLOW (LIGHT YELLOW) Score no score
Shape OVAL (Oval) Size 6mm
Flavor Imprint Code B
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65841-843-01 100 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA040597 09/04/2007
Labeler — Zydus Lifesciences Limited (918596198)
Registrant — Zydus Lifesciences Limited (918596198)
Establishment
Name Address ID/FEI Operations
Zydus Lifesciences Limited 918596198 ANALYSIS (65841-614), ANALYSIS (65841-843), MANUFACTURE (65841-614), MANUFACTURE (65841-843)

Revised: 07/2022 Zydus Lifesciences Limited

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2024. All Rights Reserved.