MedPath

Triazolam

TRIAZOLAM Tablets, USP 0.125 mg and 0.25 mg CIV

Approved
Approval ID

73db8a0e-02a9-4613-8feb-e847c965d34f

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 1, 2010

Manufacturers
FDA

Rebel Distributors Corp

DUNS: 118802834

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 Code21695-284
Application NumberANDA074224
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2009
FDA Product Classification

INGREDIENTS (7)

TRIAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

Triazolam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code21695-303
Application NumberANDA074224
Product Classification
M
Marketing Category
C73584
G
Generic Name
Triazolam
Product Specifications
Route of AdministrationORAL
Effective DateJuly 15, 2009
FDA Product Classification

INGREDIENTS (6)

TRIAZOLAMActive
Quantity: 0.125 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.

Triazolam - FDA Drug Approval Details