Phenobarbital
PHENOBARBITAL ELIXIR, USP CIV Rx only
Approved
Approval ID
7768df0e-c0c3-4ab8-bfb5-3b0a7be32f80
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 7, 2023
Manufacturers
FDA
Laser Pharmaceuticals, LLC
DUNS: 614417132
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
phenobarbital
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code16477-720
Product Classification
G
Generic Name
phenobarbital
Product Specifications
Route of AdministrationORAL
Effective DateAugust 7, 2023
FDA Product Classification
INGREDIENTS (6)
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
ALCOHOL 95%Inactive
Code: 7528N5H79B
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SUCRALOSEInactive
Code: 96K6UQ3ZD4
Classification: IACT
PHENOBARBITALActive
Quantity: 20 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB