Valium
Waylis Therapeutics LLC CIV VALIUM brand of diazepam TABLETS
Approved
Approval ID
260e2041-2bb3-482f-850e-b5d47a7bdbe6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 31, 2023
Manufacturers
FDA
Waylis Therapuetics LLC
DUNS: 117678921
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 Code80725-006
Application NumberNDA013263
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (5)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
DIAZEPAMActive
Quantity: 10 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
Diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-004
Application NumberNDA013263
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (4)
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DIAZEPAMActive
Quantity: 2 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB
Diazepam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code80725-005
Application NumberNDA013263
Product Classification
M
Marketing Category
C73594
G
Generic Name
Diazepam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 31, 2023
FDA Product Classification
INGREDIENTS (6)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
CALCIUM STEARATEInactive
Code: 776XM7047L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
DIAZEPAMActive
Quantity: 5 mg in 1 1
Code: Q3JTX2Q7TU
Classification: ACTIB