CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES, USP C-IV
Approved
Approval ID
2e198c16-a929-4028-8f96-25dd23f74b10
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Feb 7, 2023
Manufacturers
FDA
Epic Pharma, LLC
DUNS: 827915443
Products 3
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 Code42806-566
Application NumberANDA085475
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (11)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 25 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-564
Application NumberANDA085461
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (12)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
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
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code42806-565
Application NumberANDA085472
Product Classification
M
Marketing Category
C73584
G
Generic Name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Product Specifications
Route of AdministrationORAL
Effective DateFebruary 7, 2023
FDA Product Classification
INGREDIENTS (13)
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
LACTOSE MONOHYDRATEInactive
Code: EWQ57Q8I5X
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
POTASSIUM SORBATEInactive
Code: 1VPU26JZZ4
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 3Inactive
Code: PN2ZH5LOQY
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
FD&C GREEN NO. 3Inactive
Code: 3P3ONR6O1S
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB