Benzonatate
BENZONATATE CAPSULES USP, 100 mg and 200 mg
Approved
Approval ID
2630be01-1d2d-4c40-8e56-8568ea89eacf
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 27, 2023
Manufacturers
FDA
Bionpharma Inc.
DUNS: 079637826
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Benzonatate
PRODUCT DETAILS
NDC Product Code69452-144
Application NumberANDA081297
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 27, 2023
Generic NameBenzonatate
INGREDIENTS (5)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
BENZONATATEActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
Benzonatate
PRODUCT DETAILS
NDC Product Code69452-143
Application NumberANDA081297
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateDecember 27, 2023
Generic NameBenzonatate
INGREDIENTS (5)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB