benzonatate
Approved
Approval ID
18a633e8-c285-49ce-88dd-1f46b140e4d4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 1, 2019
Manufacturers
FDA
Proficient Rx LP
DUNS: 079196022
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-185
Application NumberANDA040627
Product Classification
M
Marketing Category
C73584
G
Generic Name
benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification
INGREDIENTS (8)
benzonatateActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63187-016
Application NumberANDA040627
Product Classification
M
Marketing Category
C73584
G
Generic Name
benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateNovember 1, 2019
FDA Product Classification
INGREDIENTS (8)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
benzonatateActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT