Chlordiazepoxide Hydrochloride and Clidinium Bromide

Product NDC
42582-301
11-digit product format
425820301
Labeler code
42582
Product ID
42582-301_6a1a5e03-79c6-45da-8e6b-f5122883118a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride and Clidinium Bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2011-05-04
Marketing end
0000-00-00
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE
Active strength
5 mg/1; mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS],Anticholinergic [EPC],Decreased Parasympathetic Acetylcholine Activity [PE],GI Motility Alteration [PE],Digestive/GI System Activity Alteration [PE],Cholinergic Antagonists [MoA]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42582-301-10Chlordiazepoxide Hydrochloride and Clidinium Bromide100 in 1 BOTTLE, PLASTICCAPSULE1003
42582-301-16Chlordiazepoxide Hydrochloride and Clidinium Bromide250 in 1 BOTTLE, PLASTICCAPSULE2503
42582-301-20Chlordiazepoxide Hydrochloride and Clidinium Bromide1000 in 1 BOTTLE, PLASTICCAPSULE10003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42582-301-10EA - Each42582-301820d1488-273d-4c6a-ad6d-a2e58222cdd412016-09-02
42582-301-16EA - Each42582-3017f456814-16f6-4c2f-b425-8f6bcb66faeb12016-09-02
42582-301-20EA - Each42582-301f89c8487-e8f9-41b8-9166-08932b42e09612016-09-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42582-301CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [BI-COASTAL PHARMA INTERNATIONAL LIMITED LIABILITY COMPANY]3Legacy NDC, 3 package rows20200312_d8dd70f1-b9b3-4a6a-be09-73913d1a7e51.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNd8dd70f1-b9b3-4a6a-be09-73913d1a7e513
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDd8dd70f1-b9b3-4a6a-be09-73913d1a7e513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42582-301-1042582030110100 CAPSULE in 1 BOTTLE, PLASTIC (42582-301-10) 100 capsule2011-05-040000-00-00NoNoCurrent
42582-301-1642582030116250 CAPSULE in 1 BOTTLE, PLASTIC (42582-301-16) 250 capsule2011-05-040000-00-00NoNoCurrent
42582-301-20425820301201000 CAPSULE in 1 BOTTLE, PLASTIC (42582-301-20) 1000 capsule2011-05-040000-00-00NoNoCurrent