Phenobarbital Oral Solution
Phenobarbital Oral Solution, USP CIV
Approved
Approval ID
45f6317e-cfc9-4ec9-84c9-72daa6c68911
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 30, 2023
Manufacturers
FDA
BPI Labs LLC
DUNS: 078627620
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenobarbital Oral
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code54288-163
Product Classification
G
Generic Name
Phenobarbital Oral
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2023
FDA Product Classification
INGREDIENTS (8)
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
.ALPHA.-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
ORANGEInactive
Code: 5EVU04N5QU
Classification: IACT
PHENOBARBITALActive
Quantity: 20 mg in 5 mL
Code: YQE403BP4D
Classification: ACTIB