Benzonatate
BENZONATATE CAPSULES USP, 100 mg and 200 mg
Approved
Approval ID
ef556df2-6c68-454e-87d3-8fd918908e4f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 25, 2015
Manufacturers
FDA
Banner Life Sciences LLC.
DUNS: 079579273
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 Code69387-119
Application NumberANDA081297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2015
FDA Product Classification
INGREDIENTS (5)
WATERInactive
Code: 059QF0KO0R
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
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Benzonatate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69387-120
Application NumberANDA081297
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 25, 2015
FDA Product Classification
INGREDIENTS (5)
GELATINInactive
Code: 2G86QN327L
Classification: IACT
BenzonatateActive
Quantity: 200 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT