Diazepam Intensol
Diazepam ™ Oral Solution (Concentrate), CIV 25 mg per 5 mL (5 mg/mL) Rx only
Approved
Approval ID
1aaf9375-ae3d-4fed-9cd1-24102e00be1a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Nov 16, 2022
Manufacturers
FDA
Hikma Pharmaceuticals USA Inc.
DUNS: 080189610
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Diazepam Intensol
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0054-3185
Application NumberANDA071415
Product Classification
M
Marketing Category
C73584
G
Generic Name
Diazepam Intensol
Product Specifications
Route of AdministrationORAL
Effective DateAugust 30, 2022
FDA Product Classification
INGREDIENTS (7)
DIAZEPAMActive
Quantity: 5 mg in 1 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
ALCOHOLInactive
Quantity: 190 mg in 1 mL
Code: 3K9958V90M
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SUCCINIC ACIDInactive
Code: AB6MNQ6J6L
Classification: IACT