Benzonatate
Benzonatate Capsules, USP 8221401/0921 Rx only
Approved
Approval ID
9a71725a-64b6-4800-a79c-aa4b2d74d44f
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 31, 2022
Manufacturers
FDA
American Health Packaging
DUNS: 929561009
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 Code68084-214
Application NumberANDA040597
Product Classification
M
Marketing Category
C73584
G
Generic Name
Benzonatate
Product Specifications
Route of AdministrationORAL
Effective DateAugust 31, 2022
FDA Product Classification
INGREDIENTS (7)
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB