Pentobarbital Sodium
Pentobarbital Sodium Injection, USP
Approved
Approval ID
d375b92a-baa1-4d63-9ad1-1467dcfde7d5
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 10, 2023
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc. (dba Leucadia Pharmaceuticals)
DUNS: 118707839
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 Code24201-010
Application NumberANDA203619
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pentobarbital Sodium
Product Specifications
Route of AdministrationINTRAMUSCULAR, INTRAVENOUS
Effective DateJanuary 10, 2023
FDA Product Classification
INGREDIENTS (4)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
PENTOBARBITAL SODIUMActive
Quantity: 50 mg in 1 mL
Code: NJJ0475N0S
Classification: ACTIB