Alprazolam
Alprazolam Extended-Release Tablets
Approved
Approval ID
98cc444a-2c39-4410-8020-aded0a8deb81
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 3, 2009
Manufacturers
FDA
Rebel Distributors Corp.
DUNS: 118802834
Products 4
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-602
Application NumberANDA078387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (2)
ALPRAZOLAMActive
Quantity: 0.5 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-604
Application NumberANDA078387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (1)
ALPRAZOLAMActive
Quantity: 2 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-603
Application NumberANDA078387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (1)
ALPRAZOLAMActive
Quantity: 1 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB
Alprazolam
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-605
Application NumberANDA078387
Product Classification
M
Marketing Category
C73584
G
Generic Name
Alprazolam
Product Specifications
Route of AdministrationORAL
Effective DateDecember 3, 2009
FDA Product Classification
INGREDIENTS (1)
ALPRAZOLAMActive
Quantity: 2 mg in 1 1
Code: YU55MQ3IZY
Classification: ACTIB