Clorazepate Dipotassium
Clorazepate Dipotassium Tablets USP, 3.75 mg, 7.5 mg, & 15 mg
Approved
Approval ID
a6cc08b8-146e-430f-af39-8b866698b997
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 16, 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.
Clorazepate Dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-434
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2008
FDA Product Classification
INGREDIENTS (10)
Clorazepate DipotassiumActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
D&C RED NO. 6Inactive
Code: 481744AI4O
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT
Clorazepate Dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code21695-433
Application NumberANDA075731
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate Dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateAugust 28, 2008
FDA Product Classification
INGREDIENTS (10)
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
Clorazepate DipotassiumActive
Quantity: 3.75 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
magnesium stearateInactive
Code: 70097M6I30
Classification: IACT
potassium chlorideInactive
Code: 660YQ98I10
Classification: IACT
talcInactive
Code: 7SEV7J4R1U
Classification: IACT