BENZONATATE - benzonatate capsule 
Cadila Healthcare Limited

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Benzonatate Capsules, USP

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

NDC 65841-843-01 in bottle of 100 capsules

Benzonatate Capsules USP, 200 mg

Rx only

100 capsules

Benzonatate Capsules
BENZONATATE 
benzonatate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-614
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE100 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeROUND (ROUND) Size3mm
FlavorImprint Code Z
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-614-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
2NDC:65841-614-05500 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04059709/04/2007
BENZONATATE 
benzonatate capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:65841-843
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE200 mg
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITOL (UNII: 506T60A25R)  
WATER (UNII: 059QF0KO0R)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorYELLOW (LIGHT YELLOW) Scoreno score
ShapeOVAL (Oval) Size6mm
FlavorImprint Code B
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65841-843-01100 in 1 BOTTLE; Type 0: Not a Combination Product09/04/2007
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA04059709/04/2007
Labeler - Cadila Healthcare Limited (918596198)
Registrant - Cadila Healthcare Limited (918596198)
Establishment
NameAddressID/FEIBusiness Operations
Cadila Healthcare Limited918596198ANALYSIS(65841-614, 65841-843) , MANUFACTURE(65841-614, 65841-843)

Revised: 8/2021
Document Id: 647424d0-f3b7-4128-8543-f0db0c994926
Set id: abb4360a-4c52-45b6-9b80-df3c1bfc4c59
Version: 7
Effective Time: 20210806
 
Cadila Healthcare Limited