CHLORDIAZEPOXIDE HYDROCHLORIDE

Product NDC
42806-565
11-digit product format
428060565
Labeler code
42806
Product ID
42806-565_d7a3306e-01d4-4966-a473-62136d81f959
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CHLORDIAZEPOXIDE HYDROCHLORIDE
Dosage form
CAPSULE, GELATIN COATED
Route
ORAL
Labeler
Epic Pharma, LLC
Application
ANDA085472
Marketing category
ANDA
Marketing start
2021-08-13
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, 905495, 905516

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
42806-565-01CHLORDIAZEPOXIDE HYDROCHLORIDE100 in 1 BOTTLECAPSULE, GELATIN COATED1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42806-565-01EA - Each42806-5653ed7e370-9e62-4c46-a830-1d6120b4238e12021-11-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42806-565CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE, GELATIN COATED [EPIC PHARMA, LLC]3Current NDC, Legacy NDC, 1 package rows20230209_2e198c16-a929-4028-8f96-25dd23f74b10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN2e198c16-a929-4028-8f96-25dd23f74b103
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN2e198c16-a929-4028-8f96-25dd23f74b103
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSN2e198c16-a929-4028-8f96-25dd23f74b103
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD2e198c16-a929-4028-8f96-25dd23f74b103
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD2e198c16-a929-4028-8f96-25dd23f74b103
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCD2e198c16-a929-4028-8f96-25dd23f74b103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
42806-565-0142806056501100 CAPSULE, GELATIN COATED in 1 BOTTLE (42806-565-01) 2021-08-130000-00-00NoNoCurrent