Benzonatate
Benzonatate Capsules USP, 100 mg
Approved
Approval ID
d58b2044-918c-4626-815f-957530611495
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 20, 2020
Manufacturers
FDA
Medstone Pharma LLC
DUNS: 080783388
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 Code71626-201
Application NumberANDA202765
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateMarch 20, 2020
FDA Product Classification
INGREDIENTS (8)
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
Drug Labeling Information
INDICATIONS & USAGE SECTION
LOINC: 34067-9Updated: 3/20/2020
INDICATIONS AND USAGE
Benzonatate Capsule is indicated for the symptomatic relief of cough.
CONTRAINDICATIONS SECTION
LOINC: 34070-3Updated: 3/20/2020
CONTRAINDICATIONS
Hypersensitivity to benzonatate or related compounds.