pentobarbital sodium

FDA-approved pharmaceutical product with comprehensive regulatory information, manufacturing details, and complete labeling documentation.

Company

DUNS: 796852890

Effective Date

June 30, 2017

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Pentobarbital(50 mg in 1 mL)

Products1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

NDC Product Code

25021-676

Application Number

ANDA206404

Marketing Category

ANDA (C73584)

Route of Administration

INTRAVENOUS, INTRAMUSCULAR

Effective Date

April 18, 2017

Ingredients

waterInactive

Code: 059QF0KO0RClass: IACT

Code: NJJ0475N0SClass: ACTIBQuantity: 50 mg in 1 mL

propylene glycolInactive

Code: 6DC9Q167V3Class: IACT

alcoholInactive

Code: 3K9958V90MClass: IACT

sodium hydroxideInactive

Code: 55X04QC32IClass: IACT

hydrochloric acidInactive

Code: QTT17582CBClass: IACT

Complete FDA-approved labeling information including indications, dosage, warnings, contraindications, and other essential prescribing details.

CII
SAGENT®
Rx only