Benzonatate
Benzonatate Capsules, USP 100 mg and 200 mg
Approved
Approval ID
199a42ae-4d19-4e68-934d-dabd27084988
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 18, 2023
Manufacturers
FDA
Amneal Pharmaceuticals LLC
DUNS: 123797875
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 Code65162-537
Application NumberANDA040682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (1)
BENZONATATEActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
Benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code65162-536
Application NumberANDA040682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 18, 2023
FDA Product Classification
INGREDIENTS (1)
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB