chlordiazepoxide hydrochloride and clidinium bromide
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP 5 mg/ 2.5 mg For oral useRx only
Approved
Approval ID
b4ef805f-9fc3-47f7-b1f7-328c54970e5d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 17, 2023
Manufacturers
FDA
Amneal Pharmaceuticals NY LLC
DUNS: 123797875
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 Code60219-1677
Application NumberANDA215555
Product Classification
M
Marketing Category
C73584
G
Generic Name
chlordiazepoxide hydrochloride and clidinium bromide
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 28, 2023
FDA Product Classification
INGREDIENTS (19)
CLIDINIUM BROMIDEActive
Quantity: 2.5 mg in 1 1
Code: 91ZQW5JF1Z
Classification: ACTIB
ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
AMMONIAInactive
Code: 5138Q19F1X
Classification: IACT
BUTYL ALCOHOLInactive
Code: 8PJ61P6TS3
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
HYDROGENATED CASTOR OILInactive
Code: ZF94AP8MEY
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
POTASSIUM HYDROXIDEInactive
Code: WZH3C48M4T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB