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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-652
Application NumberNDA020648
Product Classification
M
Marketing Category
C73605
G
Generic Name
diazepam
Product Specifications
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-655
Application NumberNDA020648
Product Classification
M
Marketing Category
C73605
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
FDA Product Classification
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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code68682-650
Application NumberNDA020648
Product Classification
M
Marketing Category
C73605
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationRECTAL
Effective DateJanuary 4, 2024
FDA Product Classification
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