Chlordiazepoxide Hydrochloride

Product NDC
58118-1033
11-digit product format
581181033
Labeler code
58118
Product ID
58118-1033_0e85dcfa-d9dd-5fbb-e063-6394a90aeae6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA083116
Marketing category
ANDA
Marketing start
2019-02-19
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMFM6K1XWDK
Rxcui905369

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
632cace7-5e66-44d3-b8c3-9d6af8cdd96aProduct name520250623
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58118-1033-8Chlordiazepoxide Hydrochloride30 in 1 BLISTER PACKCAPSULE305

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-1033CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [CLINICAL SOLUTIONS WHOLESALE, LLC]5Current NDC, Legacy NDC, 1 package rows20240110_74c4320d-c90d-436b-97da-07496ba88aed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN74c4320d-c90d-436b-97da-07496ba88aed5
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD74c4320d-c90d-436b-97da-07496ba88aed5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-1033-85811810330830 CAPSULE in 1 BLISTER PACK (58118-1033-8) 30 capsule2019-02-190000-00-00NoNoCurrent