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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-144
Application NumberANDA081297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69452-143
Application NumberANDA081297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateDecember 27, 2023
FDA Product Classification
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