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Chlordiazepoxide Hydrochloride

909 Chlordiazepoxide 10 mg Chlordiazepoxide Hydrochloride Capsules USP CIV Rx only

Approved
Approval ID

5aa62277-272e-df59-e053-2a91aa0a06a7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Oct 3, 2017

Manufacturers
FDA

Contract Pharmacy Services-PA

DUNS: 945429777

Products 1

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 Code67046-909
Application NumberANDA083116
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlordiazepoxide Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateOctober 3, 2017
FDA Product Classification

INGREDIENTS (16)

SODIUM LAURYL SULFATEInactive
Code: 368GB5141J
Classification: IACT
SODIUM PROPIONATEInactive
Code: DK6Y9P42IN
Classification: IACT
FD&C BLUE NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
ANHYDROUS LACTOSEInactive
Code: 3SY5LH9PMK
Classification: IACT
D&C YELLOW NO. 10Inactive
Code: 35SW5USQ3G
Classification: IACT
HYDROGENATED COTTONSEED OILInactive
Code: Z82Y2C65EA
Classification: IACT
MICROCRYSTALLINE CELLULOSEInactive
Code: OP1R32D61U
Classification: IACT
SHELLACInactive
Code: 46N107B71O
Classification: IACT
EDETATE CALCIUM DISODIUMInactive
Code: 25IH6R4SGF
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
BUTYLPARABENInactive
Code: 3QPI1U3FV8
Classification: IACT
FD&C RED NO. 40Inactive
Code: WZB9127XOA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
CHLORDIAZEPOXIDE HYDROCHLORIDEActive
Quantity: 10 mg in 1 1
Code: MFM6K1XWDK
Classification: ACTIB

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Chlordiazepoxide Hydrochloride - FDA Drug Approval Details