Clorazepate Dipotassium

Product NDC
70954-159
11-digit product format
709540159
Labeler code
70954
Product ID
70954-159_d4edcb5d-dbe9-44c4-a0a9-d3b6aba4c22d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Clorazepate Dipotassium
Dosage form
TABLET
Route
ORAL
Labeler
ANI Pharmaceuticals, Inc.
Application
ANDA213730
Marketing category
ANDA
Marketing start
2022-06-16
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
70954-159-10Clorazepate Dipotassium100 in 1 BOTTLETABLET10013
70954-159-20Clorazepate Dipotassium500 in 1 BOTTLETABLET50013
70954-159-30Clorazepate Dipotassium30 in 1 BOTTLETABLET3013
70954-159-40Clorazepate Dipotassium1 in 1 BLISTER PACKTABLET113
70954-159-50Clorazepate Dipotassium30 in 1 BOX, UNIT-DOSETABLET3013

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70954-159-10EA - Each70954-1594d201f37-b4a8-49b9-a0d4-427f95511aea12022-07-06
70954-159-30EA - Each70954-15966ddfa29-e746-4559-a6b5-94c2869fe13712023-09-05
70954-159-40EA - Each70954-159ef021671-4401-4255-978d-e5a694e8b1fc12025-07-08
70954-159-50EA - Each70954-159195dbf33-cf57-4b67-aabb-f74d7704ab0612025-07-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70954-159CLORAZEPATE DIPOTASSIUM TABLET [ANI PHARMACEUTICALS, INC.]8Current NDC, Legacy NDC, 5 package rows20250112_a4b80e69-b7c7-471a-8ce8-4e992808c669.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197464clorazepate dipotassium 15 MG Oral TabletPSNa4b80e69-b7c7-471a-8ce8-4e992808c66913
197465clorazepate dipotassium 3.75 MG Oral TabletPSNa4b80e69-b7c7-471a-8ce8-4e992808c66913
197466clorazepate dipotassium 7.5 MG Oral TabletPSNa4b80e69-b7c7-471a-8ce8-4e992808c66913
197464clorazepate dipotassium 15 MG Oral TabletSCDa4b80e69-b7c7-471a-8ce8-4e992808c66913
197465clorazepate dipotassium 3.75 MG Oral TabletSCDa4b80e69-b7c7-471a-8ce8-4e992808c66913
197466clorazepate dipotassium 7.5 MG Oral TabletSCDa4b80e69-b7c7-471a-8ce8-4e992808c66913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70954-159-1070954015910100 TABLET in 1 BOTTLE (70954-159-10) 100 tablet2022-06-160000-00-00NoNoCurrent
70954-159-2070954015920500 TABLET in 1 BOTTLE (70954-159-20) 500 tablet2022-07-010000-00-00NoNoCurrent
70954-159-307095401593030 TABLET in 1 BOTTLE (70954-159-30) 30 tablet2023-08-21NoNoHistorical
70954-159-40709540159401 in 1 BLISTER PACKHistorical
70954-159-507095401595030 BLISTER PACK in 1 BOX, UNIT-DOSE (70954-159-50) / 1 TABLET in 1 BLISTER PACK (70954-159-40) 30 blister pack2025-06-15NoNoHistorical