Label: BENZONATATE capsule
- NDC Code(s): 65841-614-01, 65841-614-05, 65841-843-01
- Packager: Zydus Lifesciences Limited
- Category: HUMAN PRESCRIPTION DRUG LABEL
Drug Label Information
Updated July 27, 2022
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INGREDIENTS AND APPEARANCE
BENZONATATE
benzonatate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-614 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 100 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape ROUND (ROUND) Size 3mm Flavor Imprint Code Z Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-614-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2007 2 NDC:65841-614-05 500 in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2007 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA040597 09/04/2007 BENZONATATE
benzonatate capsuleProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65841-843 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZONATATE (UNII: 5P4DHS6ENR) (BENZONATATE - UNII:5P4DHS6ENR) BENZONATATE 200 mg Inactive Ingredients Ingredient Name Strength GLYCERIN (UNII: PDC6A3C0OX) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) GELATIN (UNII: 2G86QN327L) Product Characteristics Color YELLOW (LIGHT YELLOW) Score no score Shape OVAL (Oval) Size 6mm Flavor Imprint Code B Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65841-843-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 09/04/2007 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 Business Operations Zydus Lifesciences Limited 918596198 ANALYSIS(65841-614, 65841-843) , MANUFACTURE(65841-614, 65841-843)
