Diazepam
Diazepam Rectal Gel C-IV Rectal Delivery System
Approved
Approval ID
b1b2848b-b265-4f6f-9141-bf106dec0726
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 4, 2024
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diazepam
PRODUCT DETAILS
NDC Product Code68682-652
Application NumberNDA020648
Marketing CategoryC73605
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
Generic Namediazepam
INGREDIENTS (8)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 2 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Diazepam
PRODUCT DETAILS
NDC Product Code68682-655
Application NumberNDA020648
Marketing CategoryC73605
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
Generic NameDiazepam
INGREDIENTS (8)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIAZEPAMActive
Quantity: 20 mg in 4 mL
Code: Q3JTX2Q7TU
Classification: ACTIB
Diazepam
PRODUCT DETAILS
NDC Product Code68682-650
Application NumberNDA020648
Marketing CategoryC73605
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
Generic NameDiazepam
INGREDIENTS (8)
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
HYPROMELLOSE, UNSPECIFIEDInactive
Code: 3NXW29V3WO
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DIAZEPAMActive
Quantity: 2.5 mg in 0.5 mL
Code: Q3JTX2Q7TU
Classification: ACTIB