BENZONATATE
BENZONATATE 100MG CAPSULE
Approved
Approval ID
05b19502-15cb-4272-8efe-6b37b1863e63
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 12, 2012
Manufacturers
FDA
Life Line Home Care Services, Inc.
DUNS: 844985374
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 Code75921-133
Application NumberANDA040587
Product Classification
M
Marketing Category
C73584
G
Generic Name
BENZONATATE
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 12, 2012
FDA Product Classification
INGREDIENTS (12)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
BENZONATATEActive
Quantity: 100 mg in 1 1
Code: 5P4DHS6ENR
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT