Clorazepate Dipotassium

Product NDC
51672-4042
11-digit product format
516724042
Labeler code
51672
Product ID
51672-4042_22e382fc-edce-24b7-e063-6394a90a35e6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clorazepate Dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
Taro Pharmaceuticals U.S.A., Inc.
Application
ANDA075731
Marketing category
ANDA
Marketing start
2000-04-27
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
3.75 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
Clorazepate Dipotassium
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLORAZEPATE DIPOTASSIUM3.75 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii63FN7G03XY
Rxcui197464, 197465, 197466

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
92da8c14-4fd1-b0be-b744-e53fd3862208Product name220230310
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4042-1Clorazepate Dipotassium100 in 1 BOTTLETABLET1007
51672-4042-2Clorazepate Dipotassium500 in 1 BOTTLETABLET5007
51672-4042-3Clorazepate Dipotassium1000 in 1 BOTTLETABLET10007

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4042-1EA - Each51672-40420ea7a82a-26de-4b5a-9315-c41ad50f087d12012-07-24
51672-4042-2EA - Each51672-40421ff5ed09-17d7-470e-814d-090d365b7a2712012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Clorazepate DipotassiumACTIVE INGREDIENT63FN7G03XYCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Clorazepic AcidACTIVE MOIETYD51WO0G0L4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Aluminum OxideINACTIVE INGREDIENTLMI26O6933CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
cellulose, microcrystallineINACTIVE INGREDIENTOP1R32D61UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Red No. 6INACTIVE INGREDIENT481744AI4OCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
FD&C Red No. 40INACTIVE INGREDIENTWZB9127XOACLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
magnesium stearateINACTIVE INGREDIENT70097M6I30CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
potassium chlorideINACTIVE INGREDIENT660YQ98I10CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
talcINACTIVE INGREDIENT7SEV7J4R1UCLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]2
Clorazepate DipotassiumACTIVE INGREDIENT63FN7G03XYCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
Clorazepic acidACTIVE MOIETYD51WO0G0L4CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
D&C RED NO. 6INACTIVE INGREDIENT481744AI4OCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQKCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOACLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
MAGNESIUM OXIDEINACTIVE INGREDIENT3A3U0GI71GCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
POTASSIUM CARBONATEINACTIVE INGREDIENTBQN1B9B9HACLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
potassium chlorideINACTIVE INGREDIENT660YQ98I10CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4CLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1
talcINACTIVE INGREDIENT7SEV7J4R1UCLORAZEPATE DIPOTASSIUM TABLET [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4042CLORAZEPATE DIPOTASSIUM TABLET [TARO PHARMACEUTICALS U.S.A., INC.]7Current NDC, Legacy NDC, 3 package rows20240926_499a6989-8912-44b7-b1eb-ee8f85ae378f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197464clorazepate dipotassium 15 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197466clorazepate dipotassium 7.5 MG Oral TabletPSN499a6989-8912-44b7-b1eb-ee8f85ae378f7
197464clorazepate dipotassium 15 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197466clorazepate dipotassium 7.5 MG Oral TabletSCD499a6989-8912-44b7-b1eb-ee8f85ae378f7
197465clorazepate dipotassium 3.75 MG Oral TabletPSNa6cc08b8-146e-430f-af39-8b866698b9971
197466clorazepate dipotassium 7.5 MG Oral TabletPSNa6cc08b8-146e-430f-af39-8b866698b9971
197465clorazepate dipotassium 3.75 MG Oral TabletSCDa6cc08b8-146e-430f-af39-8b866698b9971
197466clorazepate dipotassium 7.5 MG Oral TabletSCDa6cc08b8-146e-430f-af39-8b866698b9971

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4042-151672404201100 TABLET in 1 BOTTLE (51672-4042-1) 100 tablet2000-04-270000-00-00NoNoCurrent
51672-4042-251672404202500 TABLET in 1 BOTTLE (51672-4042-2) 500 tablet2000-04-270000-00-00NoNoCurrent
51672-4042-3516724042031000 TABLET in 1 BOTTLE (51672-4042-3) 1000 tablet2000-04-270000-00-00NoNoCurrent