chlordiazepoxide hydrochloride and clidinium bromide

Product NDC
60219-1677
11-digit product format
602191677
Labeler code
60219
Product ID
60219-1677_4c4923d9-915c-441a-90ee-fca641301d6e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
chlordiazepoxide hydrochloride and clidinium bromide
Dosage form
CAPSULE
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA215555
Marketing category
ANDA
Marketing start
2021-10-25
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1677-1chlordiazepoxide hydrochloride and clidinium bromide100 in 1 BOTTLE, PLASTICCAPSULE10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1677-1EA - Each60219-16775c1ef0ff-101c-4591-88e0-92f0b92c6a1e12022-01-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1677CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE CAPSULE [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 1 package rows20250107_b4ef805f-9fc3-47f7-b1f7-328c54970e5d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
889614chlordiazePOXIDE HCl 5 MG / clidinium bromide 2.5 MG Oral CapsulePSNb4ef805f-9fc3-47f7-b1f7-328c54970e5d12
889614chlordiazepoxide hydrochloride 5 MG / clidinium bromide 2.5 MG Oral CapsuleSCDb4ef805f-9fc3-47f7-b1f7-328c54970e5d12

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
60219-1677-160219167701100 CAPSULE in 1 BOTTLE, PLASTIC (60219-1677-1) 100 capsule2021-10-250000-00-00NoNoCurrent