FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
0276-0500
11-digit product format
002760500
Labeler code
0276
Product ID
0276-0500_4139e8c6-5256-6934-e063-6294a90aa5a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride, Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Misemer Pharmaceuticals, Inc
Application
ANDA210579
Marketing category
ANDA
Marketing start
2020-09-03
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

Additional Listing Data#

Finished product
Yes
Brand name base
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE5 mg/1
CLIDINIUM BROMIDE2.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMFM6K1XWDK, 91ZQW5JF1Z
Rxcui889614

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0276-0500-102025-12-04C16284748780-1f386c649-ae1f-0266-e053-dadaa90a7c1aChlordiazepoxide Hydrochloride and Clidinium Bromide Capsules WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS). • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and
0276-0500-102023-01-30C16284748780-1f386c649-ae1f-0266-e053-dadaa90a7c1aChlordiazepoxide Hydrochloride and Clidinium Bromide Capsules WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death (see WARNINGS and PRECAUTIONS). • Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. • Limit dosages and durations to the minimum required. • Follow patients for signs and symptoms of respiratory depression and

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0276-0500-10Chlordiazepoxide Hydrochloride and Clidinium Bromide100 in 1 BOTTLECAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0276-0500NOT APPLICABLE (CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULES) CAPSULE [MISEMER PHARMACEUTICALS, INC]4Current NDC, Legacy NDC, 1 package rows20211228_a42fc981-77bc-4c9e-a79d-b821bffb65b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNa42fc981-77bc-4c9e-a79d-b821bffb65b45
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDa42fc981-77bc-4c9e-a79d-b821bffb65b45

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0276-0500-1000276050010100 CAPSULE in 1 BOTTLE (0276-0500-10) 100 capsule2020-09-030000-00-00NoNoCurrent