Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
71335-9764
11-digit product format
713359764
Labeler code
71335
Product ID
71335-9764_14333b2e-2e13-424d-819a-b08667725247
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211421
Marketing category
ANDA
Marketing start
2020-07-09
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active strength
5; 2.5 mg/1; mg/1
Pharmacologic classes
Anticholinergic [EPC], Benzodiazepine [EPC], Benzodiazepines [CS], Cholinergic Antagonists [MoA], Decreased Parasympathetic Acetylcholine Activity [PE], Digestive/GI System Activity Alteration [PE], GI Motility Alteration [PE]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
MFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE438-41-5CHLORDIAZEPOXIDE HYDROCHLORIDE
91ZQW5JF1ZCLIDINIUM BROMIDE3485-62-9CLIDINIUM BROMIDE

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-9764-171335976401100 CAPSULE in 1 BOTTLE (71335-9764-1) 100 capsule2023-08-15NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP for oral useBryant Ranch Prepack2023-08-15HUMAN PRESCRIPTION DRUG LABEL100