CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV
Approved
Approval ID
8255992f-3256-4558-bd0d-cfe350d95f25
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 8, 2022
Manufacturers
FDA
Epic Pharma LLC
DUNS: 827915443
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHLORDIAZEPOXIDE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code42806-562
Application NumberANDA085472
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 8, 2022
Generic NameCHLORDIAZEPOXIDE HYDROCHLORIDE
INGREDIENTS (14)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB
CHLORDIAZEPOXIDE HYDROCHLORIDE
PRODUCT DETAILS
NDC Product Code42806-563
Application NumberANDA085475
Marketing CategoryC73584
Route of AdministrationORAL
Effective DateMarch 8, 2022
Generic NameCHLORDIAZEPOXIDE HYDROCHLORIDE
INGREDIENTS (12)
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB