FDA.reportPublic FDA data

Chlordiazepoxide Hydrochloride

Product NDC
43063-046
11-digit product format
430630046
Labeler code
43063
Product ID
43063-046_3edd1001-c580-bf18-e063-6394a90a3c31
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Chlordiazepoxide Hydrochloride
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA084769
Marketing category
ANDA
Marketing start
1976-07-01
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
Rxcui905495

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
43063-046-03Chlordiazepoxide Hydrochloride3 in 1 BOTTLE, PLASTICCAPSULE319
43063-046-06Chlordiazepoxide Hydrochloride6 in 1 BOTTLE, PLASTICCAPSULE619
43063-046-12Chlordiazepoxide Hydrochloride12 in 1 BOTTLE, PLASTICCAPSULE1219
43063-046-15Chlordiazepoxide Hydrochloride15 in 1 BOTTLE, PLASTICCAPSULE1519
43063-046-19Chlordiazepoxide Hydrochloride19 in 1 BOTTLE, PLASTICCAPSULE1919
43063-046-24Chlordiazepoxide Hydrochloride24 in 1 BOTTLE, PLASTICCAPSULE2419

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-046-03EA - Each43063-046ccfcf470-c38b-43c4-9a67-ad829973ba0d12012-07-24
43063-046-06EA - Each43063-04679a016b8-1448-4ef9-8923-4cad8eb3405d12012-07-24
43063-046-12EA - Each43063-046bed3c61c-5bf8-4fd6-89fb-b406a702c47212012-07-24
43063-046-15EA - Each43063-0464599f917-44cb-4c73-8a85-da339b39120512012-07-24
43063-046-19EA - Each43063-0466a171e4f-3297-4562-b40c-9375fece5ae812012-07-24
43063-046-24EA - Each43063-046daf5cd85-066c-4666-ab3c-435012c97b3512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CHLORDIAZEPOXIDE HYDROCHLORIDEACTIVE INGREDIENTMFM6K1XWDKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
CHLORDIAZEPOXIDEACTIVE MOIETY6RZ6XEZ3CRCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
GELATININACTIVE INGREDIENT2G86QN327LCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
SHELLACINACTIVE INGREDIENT46N107B71OCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPCHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-046CHLORDIAZEPOXIDE HYDROCHLORIDE CAPSULE [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 6 package rows20240922_3cbd7cee-c4d7-4c95-93d8-09428169b937.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905495chlordiazePOXIDE HCl 25 MG Oral CapsulePSN3cbd7cee-c4d7-4c95-93d8-09428169b93719
905495chlordiazepoxide hydrochloride 25 MG Oral CapsuleSCD3cbd7cee-c4d7-4c95-93d8-09428169b93719

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43063-046-03430630046033 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-03) 3 capsule2010-12-060000-00-00NoNoCurrent
43063-046-06430630046066 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-06) 6 capsule2010-12-060000-00-00NoNoCurrent
43063-046-124306300461212 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-12) 12 capsule2010-12-060000-00-00NoNoCurrent
43063-046-154306300461515 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-15) 15 capsule2010-12-060000-00-00NoNoCurrent
43063-046-194306300461919 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-19) 19 capsule2010-12-060000-00-00NoNoCurrent
43063-046-244306300462424 CAPSULE in 1 BOTTLE, PLASTIC (43063-046-24) 24 capsule2010-12-060000-00-00NoNoCurrent