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
NDC Product Code71626-201
Application NumberANDA202765
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 20, 2020
Generic NameBenzonatate
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.