Chlordiazepoxide Hydrochloride
Chlordiazepoxide Hydrochloride Capsules USP CIV Rx only
Approved
Approval ID
3d4cab96-8a67-4d26-a9cc-b1a02fb6c146
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 9, 2024
Manufacturers
FDA
Clinical Solutions Wholesale, LLC
DUNS: 078710347
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlordiazepoxide Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code58118-1590
Application NumberANDA084769
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 9, 2024
FDA Product Classification
INGREDIENTS (14)
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB