benzonatate
Benzonatate Capsules, USP100 mg, 150 mg and 200 mg
Approved
Approval ID
54374c04-63b9-49fa-b6a2-4a711e322d8e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2018
Manufacturers
FDA
Ascend Laboratories LLC
DUNS: 141250469
Products 3
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 Code67877-574
Application NumberANDA201209
Product Classification
M
Marketing Category
C73584
G
Generic Name
benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2017
FDA Product Classification
INGREDIENTS (8)
benzonatateActive
Quantity: 150 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
gelatinInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
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
benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-575
Application NumberANDA040749
Product Classification
M
Marketing Category
C73584
G
Generic Name
benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2017
FDA Product Classification
INGREDIENTS (8)
benzonatateActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67877-573
Application NumberANDA040627
Product Classification
M
Marketing Category
C73584
G
Generic Name
benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 22, 2017
FDA Product Classification
INGREDIENTS (8)
benzonatateActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT
glycerinInactive
Code: PDC6A3C0OX
Classification: IACT
propylparabenInactive
Code: Z8IX2SC1OH
Classification: IACT
methylparabenInactive
Code: A2I8C7HI9T
Classification: IACT
titanium dioxideInactive
Code: 15FIX9V2JP
Classification: IACT
gelatinInactive
Code: 2G86QN327L
Classification: IACT