Chlordiazepoxide Hydrochloride

Product NDC
48433-019
11-digit product format
484330019
Labeler code
48433
Product ID
48433-019_4ee13916-80ce-b81a-e063-6294a90a6146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Safecor Health, LLC
Application
ANDA083116
Marketing category
ANDA
Marketing start
2026-03-30
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Chlordiazepoxide Hydrochloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CHLORDIAZEPOXIDE HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiMFM6K1XWDK
Rxcui905369, 905495

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
48433-019-01Chlordiazepoxide Hydrochloride1 in 1 BLISTER PACKCAPSULE12
48433-019-20Chlordiazepoxide Hydrochloride100 in 1 CARTONCAPSULE1002

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD60abf20f-0c6c-43b9-8b55-f4957e2a655d2
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD60abf20f-0c6c-43b9-8b55-f4957e2a655d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
48433-019-01484330019011 in 1 BLISTER PACKHistorical
48433-019-2048433001920100 BLISTER PACK in 1 CARTON (48433-019-20) / 1 CAPSULE in 1 BLISTER PACK (48433-019-01) 100 blister pack2026-03-30NoNoHistorical