FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
59651-524
11-digit product format
596510524
Labeler code
59651
Product ID
59651-524_0fda7521-a452-4bac-953d-7d464d75ca22
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA216419
Marketing category
ANDA
Marketing start
2023-09-14
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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-524-01Chlordiazepoxide Hydrochloride and Clidinium Bromide100 in 1 BOTTLECAPSULE1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-524-01EA - Each59651-524f9efee27-6435-4529-8a37-29a34ca817ae12024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-524CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [AUROBINDO PHARMA LIMITED]1Current NDC, 1 package rows20230920_0fda7521-a452-4bac-953d-7d464d75ca22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN0fda7521-a452-4bac-953d-7d464d75ca221
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD0fda7521-a452-4bac-953d-7d464d75ca221

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-524-0159651052401100 CAPSULE in 1 BOTTLE (59651-524-01) 100 capsule2023-09-14NoNoHistorical