CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE

Product NDC
42571-381
11-digit product format
425710381
Labeler code
42571
Product ID
42571-381_fa3753a6-a410-6ae8-e053-6394a90a0106
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE
Dosage form
CAPSULE
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA215835
Marketing category
ANDA
Marketing start
2022-10-01
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 HCL 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-381-01CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE100 in 1 BOTTLECAPSULE1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42571-381-01EA - Each42571-3811c79487b-7515-41f5-88aa-be2e287599b812023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42571-381CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE (CHLORDIAZEPOXIDE HCL AND CLIDINIUM BROMIDE) CAPSULE [MICRO LABS LIMITED]3Current NDC, Legacy NDC, 1 package rows20230427_cd820fcb-b6a8-43f4-a6d9-f94546d380c8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNec7733c5-3aad-496a-8007-5d7596ede630101
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDec7733c5-3aad-496a-8007-5d7596ede630101
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNcd820fcb-b6a8-43f4-a6d9-f94546d380c83
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDcd820fcb-b6a8-43f4-a6d9-f94546d380c83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42571-381-0142571038101100 CAPSULE in 1 BOTTLE (42571-381-01) 100 capsule2022-10-010000-00-00NoNoCurrent