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Phenobarbital Sodium

Phenobarbital Sodium Injection, USP

Approved
Approval ID

9091250d-694a-4593-84dc-6fe54aef495f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jun 5, 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 Code42494-442
Product Classification
G
Generic Name
PHENOBARBITAL SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (6)

PHENOBARBITAL SODIUMActive
Quantity: 130 mg in 1 mL
Code: SW9M9BB5K3
Classification: ACTIB
AlcoholInactive
Code: 3K9958V90M
Classification: IACT
Propylene GlycolInactive
Code: 6DC9Q167V3
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Benzyl AlcoholInactive
Code: LKG8494WBH
Classification: IACT
Hydrochloric AcidInactive
Code: QTT17582CB
Classification: IACT

PHENOBARBITAL SODIUM

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code42494-441
Product Classification
G
Generic Name
PHENOBARBITAL SODIUM
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateJune 5, 2023
FDA Product Classification

INGREDIENTS (6)

AlcoholInactive
Code: 3K9958V90M
Classification: IACT
PHENOBARBITAL SODIUMActive
Quantity: 65 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

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Phenobarbital Sodium - FDA Drug Approval Details