Chlordiazepoxide Hydrochloride and Clidinium Bromide

Basic Information

Product Name

FDA Product Code

60687-639

Regulatory Information

NDC Product Code

60687-639

Application Number

ANDA214065

Marketing Category

C73584

Effective Date

June 20, 2023

Territorial Authority

USA

FDA Title

Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP Rx Only 8463994/0423F

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Version Number

Active Ingredients

LACTOSE MONOHYDRATE

Code: EWQ57Q8I5X

Class Code: IACT

TALC

Code: 7SEV7J4R1U

Class Code: IACT

STARCH, CORN

Code: O8232NY3SJ

Class Code: IACT

D&C YELLOW NO. 10

Code: 35SW5USQ3G

Class Code: IACT

TITANIUM DIOXIDE

Code: 15FIX9V2JP

Class Code: IACT

FD&C BLUE NO. 1

Code: H3R47K3TBD

Class Code: IACT

GELATIN, UNSPECIFIED

Code: 2G86QN327L

Class Code: IACT

PROPYLENE GLYCOL

Code: 6DC9Q167V3

Class Code: IACT

CLIDINIUM BROMIDE

Quantity: 2.5 mg in 1 1

Code: 91ZQW5JF1Z

Class Code: ACTIB

SHELLAC

Code: 46N107B71O

Class Code: IACT

FERROSOFERRIC OXIDE

Code: XM0M87F357

Class Code: IACT

POTASSIUM HYDROXIDE

Code: WZH3C48M4T

Class Code: IACT

CHLORDIAZEPOXIDE HYDROCHLORIDE

Quantity: 5 mg in 1 1

Code: MFM6K1XWDK

Class Code: ACTIB

Active Moieties