FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride

Product NDC
0555-0158
11-digit product format
005550158
Labeler code
0555
Product ID
0555-0158_0e32450e-ff0c-4ab8-aeb7-34bc9fcc1962
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA084768
Marketing category
ANDA
Marketing start
1976-07-01
Substance
CHLORDIAZEPOXIDE HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316
6f1277d7-db3a-63fa-be84-d390d1482706Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0555-0158-02Chlordiazepoxide Hydrochloride100 in 1 BOTTLECAPSULE10016
0555-0158-04Chlordiazepoxide Hydrochloride500 in 1 BOTTLECAPSULE50016

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0555-0158-02EA - Each0555-0158683dba1e-b803-488b-aef9-7877286c8a0c12012-07-24
0555-0158-04EA - Each0555-015801817ee7-3f09-4fcf-9aaf-ca91e75bfb3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV8CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
ETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTIDK7C2HS09CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
LECITHIN, SOYBEANINACTIVE INGREDIENT1DI56QDM62CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
SODIUM PROPIONATEINACTIVE INGREDIENTDK6Y9P42INCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [BARR LABORATORIES INC.]4
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, INC.]3
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [MYLAN INSTITUTIONAL INC.]3
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PHYSICIANS TOTAL CARE, 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
0555-0158CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [TEVA PHARMACEUTICALS USA, INC.]15Current NDC, Legacy NDC, 2 package rows20240813_e3ff8641-ae8a-4016-acb1-cb1b7890f5ed.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSNf04714bc-4ce0-4693-9cd8-578919325474101
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCDf04714bc-4ce0-4693-9cd8-578919325474101
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
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSNe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCDe3ff8641-ae8a-4016-acb1-cb1b7890f5ed16
905369chlordiazePOXIDE HCl 10 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSN82af38e7-33d7-4c68-8fa8-c753762bd60e3
905369chlordiazepoxide hydrochloride 10 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCD82af38e7-33d7-4c68-8fa8-c753762bd60e3
905516chlordiazePOXIDE HCl 5 MG Oral CapsulePSNa00dd797-364f-2d2c-e053-2a95a90a90551
905516chlordiazepoxide hydrochloride 5 MG Oral CapsuleSCDa00dd797-364f-2d2c-e053-2a95a90a90551

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0555-0158-0200555015802100 CAPSULE in 1 BOTTLE (0555-0158-02) 100 capsule1976-07-010000-00-00NoNoCurrent
0555-0158-0400555015804500 CAPSULE in 1 BOTTLE (0555-0158-04) 500 capsule1976-07-010000-00-00NoNoCurrent