Benzonatate
Benzonatate Capsules, USP
Approved
Approval ID
9b35e9d5-7d72-4f51-a245-ad2467ab40e9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 21, 2018
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
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 Code42806-714
Application NumberANDA206948
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2018
FDA Product Classification
INGREDIENTS (10)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-715
Application NumberANDA206948
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 21, 2018
FDA Product Classification
INGREDIENTS (10)
BENZONATATEActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
LIGHT MINERAL OILInactive
Code: N6K5787QVP
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT