CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules USP, 5 mg/2.5 mg
Approved
Approval ID
a0d735c2-e7a9-4843-a78d-203c9598682d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 5, 2023
Manufacturers
FDA
Chartwell RX, LLC
DUNS: 079394054
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 Code62135-696
Application NumberANDA213530
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Product Specifications
Route of AdministrationORAL
Effective DateOctober 5, 2023
FDA Product Classification
INGREDIENTS (14)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
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
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
CLIDINIUM BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: 91ZQW5JF1Z
Classification: ACTIB
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB