Guaifenesin
Guaifenesin
Approved
Approval ID
d1d94d37-4423-4914-9d86-c5ca6d5122f6
Product Type
HUMAN OTC DRUG LABEL
Effective Date
Apr 22, 2025
Manufacturers
FDA
AMERISOURCE BERGEN
DUNS: 007914906
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Guaifenesin
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code46122-750
Application NumberANDA209254
Product Classification
M
Marketing Category
C73584
G
Generic Name
Guaifenesin
Product Specifications
Route of AdministrationORAL
Effective DateApril 22, 2025
FDA Product Classification
INGREDIENTS (6)
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
GUAIFENESINActive
Quantity: 600 mg in 1 1
Code: 495W7451VQ
Classification: ACTIB
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT