Chlordiazepoxide Hydrochloride and Clidinium Bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP for oral use
Approved
Approval ID
c3223f35-1baf-46bf-9eb3-55455f672d85
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 14, 2023
Manufacturers
FDA
Bryant Ranch Prepack
DUNS: 171714327
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code63629-2373
Application NumberANDA211421
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Product Specifications
Route of AdministrationORAL
Effective DateJune 24, 2022
FDA Product Classification
INGREDIENTS (9)
CLIDINIUM BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: 91ZQW5JF1Z
Classification: ACTIB
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB