Chlordiazepoxide Hydrochloride

Product NDC
51079-141
11-digit product format
510790141
Labeler code
51079
Product ID
51079-141_4358ac27-671d-8c3d-e063-6394a90ae79f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA084769
Marketing category
ANDA
Marketing start
2022-06-01
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
25 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 HYDROCHLORIDE25 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51079-141-01Chlordiazepoxide Hydrochloride1 in 1 BLISTER PACKCAPSULE119
51079-141-20Chlordiazepoxide Hydrochloride100 in 1 CARTONCAPSULE10019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-141-01EA - Each51079-14111261708-a3d0-4f6a-b5ba-4b2b21e99afa12012-07-24
51079-141-20EA - Each51079-141a0b01049-113d-4187-b063-1190296606fe12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-141CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]16Current NDC, Legacy NDC, 2 package rows20241009_68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSN68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCD68c7d8a7-08b3-4a1a-acbd-09bbe67b8d4a19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-141-01510790141011 in 1 BLISTER PACKHistorical
51079-141-2051079014120100 BLISTER PACK in 1 CARTON (51079-141-20) / 1 CAPSULE in 1 BLISTER PACK (51079-141-01) 100 blister pack2022-06-010000-00-00NoNoCurrent