Triazolam
These highlights do not include all the information needed to use TRIAZOLAM TABLETS safely and effectively. See full prescribing information for TRIAZOLAM TABLETS. TRIAZOLAM tablets, for oral use, CIV Initial U.S. Approval: 1982
Approved
Approval ID
a0c99f0b-4122-4611-9b53-80fadfceacb6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 1, 2023
Manufacturers
FDA
Ingenus Pharmaceuticals, LLC
DUNS: 833250017
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 Code50742-646
Application NumberANDA214219
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2020
FDA Product Classification
INGREDIENTS (9)
TRIAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
DOCUSATE SODIUM/SODIUM BENZOATEInactive
Code: 656HXR6YXN
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
Triazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code50742-645
Application NumberANDA214219
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateOctober 30, 2020
FDA Product Classification
INGREDIENTS (8)
TRIAZOLAMActive
Quantity: 0.125 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
SODIUM STARCH GLYCOLATE TYPE A POTATOInactive
Code: 5856J3G2A2
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
DOCUSATE SODIUM/SODIUM BENZOATEInactive
Code: 656HXR6YXN
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT