FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
75826-134
11-digit product format
758260134
Labeler code
75826
Product ID
75826-134_3de77685-67e3-815d-e063-6394a90a0fdb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Winder Laboratories LLC
Application
ANDA212344
Marketing category
ANDA
Marketing start
2020-12-07
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Listing expiration
2027-12-31

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75826-134-10Chlordiazepoxide Hydrochloride and Clidinium Bromide100 in 1 BOTTLE, PLASTICCAPSULE1005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75826-134CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [WINDER LABORATORIES LLC]4Current NDC, 1 package rows20241009_87d1a147-d3c3-4097-aac0-4b19c49eabe3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSN87d1a147-d3c3-4097-aac0-4b19c49eabe35
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCD87d1a147-d3c3-4097-aac0-4b19c49eabe35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
75826-134-1075826013410100 CAPSULE in 1 BOTTLE, PLASTIC (75826-134-10) 100 capsule2020-12-07NoNoCurrent