Triazolam
Triazolam Tablets, USP CIV
Approved
Approval ID
4084da13-5825-4399-ad69-de701508c71d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2023
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Triazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1162
Application NumberANDA213003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (10)
D&C RED NO. 27Inactive
Code: 2LRS185U6K
Classification: IACT
TRIAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
Triazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1576
Application NumberANDA213003
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2023
FDA Product Classification
INGREDIENTS (8)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POVIDONEInactive
Code: FZ989GH94E
Classification: IACT
TRIAZOLAMActive
Quantity: 0.125 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT