Chlordiazepoxide Hydrochloride
CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULES USP CIV
Approved
Approval ID
82af38e7-33d7-4c68-8fa8-c753762bd60e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 28, 2011
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-2361
Application NumberANDA084769
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (13)
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code54868-2463
Application NumberANDA084768
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (14)
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C RED NO. 33Inactive
Code: 9DBA0SBB0L
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
FERROSOFERRIC OXIDEInactive
Code: XM0M87F357
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
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 Code54868-0070
Application NumberANDA083116
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateDecember 28, 2011
FDA Product Classification
INGREDIENTS (18)
ALUMINUM OXIDEInactive
Code: LMI26O6933
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
ETHYLENE GLYCOL MONOETHYL ETHERInactive
Code: IDK7C2HS09
Classification: IACT
DIMETHICONEInactive
Code: 92RU3N3Y1O
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
LECITHIN, SOYBEANInactive
Code: 1DI56QDM62
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB