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
41806094-5a00-4c24-9176-1d64055af2d8
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
PD-Rx Pharmaceuticals, Inc.
DUNS: 156893695
Products 1
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 Code43063-996
Application NumberANDA074224
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 14, 2023
FDA Product Classification
INGREDIENTS (7)
DOCUSATE SODIUM/SODIUM BENZOATEInactive
Code: 656HXR6YXN
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
TRIAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT