pentobarbital sodium
Pentobarbital Sodium Injection, USP VialsDO NOT USE IF MATERIAL HAS PRECIPITATED
Approved
Approval ID
e9f4b344-b092-4eec-b49d-d8cfe8ebc05d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jun 30, 2017
Manufacturers
FDA
Sagent Pharmaceuticals
DUNS: 796852890
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
pentobarbital sodium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code25021-676
Application NumberANDA206404
Product Classification
M
Marketing Category
C73584
G
Generic Name
pentobarbital sodium
Product Specifications
Route of AdministrationINTRAVENOUS, INTRAMUSCULAR
Effective DateApril 18, 2017
FDA Product Classification
INGREDIENTS (6)
waterInactive
Code: 059QF0KO0R
Classification: IACT
pentobarbital sodiumActive
Quantity: 50 mg in 1 mL
Code: NJJ0475N0S
Classification: ACTIB
propylene glycolInactive
Code: 6DC9Q167V3
Classification: IACT
alcoholInactive
Code: 3K9958V90M
Classification: IACT
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
hydrochloric acidInactive
Code: QTT17582CB
Classification: IACT
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 6/30/2017
CII
SAGENT®
Rx only