Chlordiazepoxide hydrochloride and clidinium bromide

Product NDC
62332-744
11-digit product format
623320744
Labeler code
62332
Product ID
62332-744_fee5919a-554b-4767-8ab2-867de799a533
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide hydrochloride and clidinium bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA216969
Marketing category
ANDA
Marketing start
2023-10-04
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
62332-744-3162332074431100 CAPSULE in 1 BOTTLE (62332-744-31) 100 capsule2023-10-04NoNoHistorical
62332-744-91623320744911000 CAPSULE in 1 BOTTLE (62332-744-91) 1000 capsule2023-10-04NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Chlordiazepoxide Hydrochloride and Clidinium Bromide Capsules, USP for oral useAlembic Pharmaceuticals Inc. | Alembic Pharmaceuticals Limited2023-10-05Human Prescription Drug Label5