Phenobarbital Sodium
Phenobarbital Sodium Injection, USP
Approved
Approval ID
50e73787-ede1-4839-aaa5-806e25f18b1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 27, 2023
Manufacturers
FDA
Cameron Pharmaceuticals
DUNS: 078371442
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 Code42494-416
Product Classification
G
Generic Name
Phenobarbital Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateFebruary 26, 2020
FDA Product Classification
INGREDIENTS (6)
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Phenobarbital SodiumActive
Quantity: 130 mg in 1 mL
Code: SW9M9BB5K3
Classification: ACTIB
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
Benzyl AlcoholInactive
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 Code42494-415
Product Classification
G
Generic Name
Phenobarbital Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateFebruary 26, 2020
FDA Product Classification
INGREDIENTS (6)
Phenobarbital SodiumActive
Quantity: 65 mg in 1 mL
Code: SW9M9BB5K3
Classification: ACTIB
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT