Phenobarbital Sodium
Approved
Approval ID
472da201-698e-4d2b-8c53-595461d85bb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 5, 2023
Manufacturers
FDA
Nexus Pharmaceuticals, LLC
DUNS: 620714787
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Phenobarbital Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-127
Product Classification
G
Generic Name
Phenobarbital Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
Phenobarbital SodiumActive
Quantity: 65 mg in 1 mL
Code: SW9M9BB5K3
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.1 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 0.678 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 0.015 mL in 1 mL
Code: LKG8494WBH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Phenobarbital Sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code14789-128
Product Classification
G
Generic Name
Phenobarbital Sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateDecember 5, 2023
FDA Product Classification
INGREDIENTS (6)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
Phenobarbital SodiumActive
Quantity: 130 mg in 1 mL
Code: SW9M9BB5K3
Classification: ACTIB
ALCOHOLInactive
Quantity: 0.1 mL in 1 mL
Code: 3K9958V90M
Classification: IACT
PROPYLENE GLYCOLInactive
Quantity: 0.678 mL in 1 mL
Code: 6DC9Q167V3
Classification: IACT
BENZYL ALCOHOLInactive
Quantity: 0.015 mL in 1 mL
Code: LKG8494WBH
Classification: IACT