Clorazepate dipotassium
904 Clorazepate 7.5 mg 907 Clorazepate 15 mg
Approved
Approval ID
5a409d46-bebf-1e76-e053-2a91aa0ac626
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 28, 2017
Manufacturers
FDA
Contract Pharmacy Services-PA
DUNS: 945429777
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 Code67046-904
Application NumberANDA076911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2017
FDA Product Classification
INGREDIENTS (8)
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
CLORAZEPATE DIPOTASSIUMActive
Quantity: 7.5 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
Clorazepate dipotassium
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code67046-907
Application NumberANDA076911
Product Classification
M
Marketing Category
C73584
G
Generic Name
Clorazepate dipotassium
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 28, 2017
FDA Product Classification
INGREDIENTS (8)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM OXIDEInactive
Code: 3A3U0GI71G
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
POTASSIUM CARBONATEInactive
Code: BQN1B9B9HA
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
CLORAZEPATE DIPOTASSIUMActive
Quantity: 15 mg in 1 1
Code: 63FN7G03XY
Classification: ACTIB
Drug Labeling Information
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 9/28/2017
Repackaged by:
Contract Pharmacy Services-PA
125 Titus Ave Suite 200
Warrington, PA 18976 USA
Rev: Original—2017.09.28—NJW