Benzonatate
Benzonatate Capsules, USP 100 mg and 200 mg
Approved
Approval ID
ce85fa92-783e-4f71-b7ae-bc0eb0410e13
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 16, 2012
Manufacturers
FDA
Rebel Distributors Corp
DUNS: 118802834
Products 1
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 Code42254-078
Application NumberANDA040682
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 13, 2010
FDA Product Classification
INGREDIENTS (6)
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
METHYLPARABEN SODIUMInactive
Code: CR6K9C2NHK
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLPARABEN SODIUMInactive
Code: 625NNB0G9N
Classification: IACT