CLORAZEPATE DIPOTASSIUM

Product NDC
13107-319
11-digit product format
131070319
Labeler code
13107
Product ID
13107-319_5da093d0-dc77-4240-97f1-d1e0ccc622ff
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
CLORAZEPATE DIPOTASSIUM
Dosage form
TABLET
Route
ORAL
Labeler
Aurolife Pharma LLC
Application
ANDA071858
Marketing category
ANDA
Marketing start
1987-07-17
Marketing end
2027-02-28
Substance
CLORAZEPATE DIPOTASSIUM
Active strength
3.75 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
CLORAZEPATE DIPOTASSIUM

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
92da8c14-4fd1-b0be-b744-e53fd3862208Product name220230310
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13107-319-01CLORAZEPATE DIPOTASSIUM100 in 1 BOTTLETABLET1005
13107-319-05CLORAZEPATE DIPOTASSIUM500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-319-01EA - Each13107-3197c779d54-260e-4e02-ad80-72c4cfd69ce312021-12-08
13107-319-05EA - Each13107-319d00593e6-62a5-48a3-bf2a-af9f2b41332212021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-319CLORAZEPATE DIPOTASSIUM TABLET [AUROLIFE PHARMA, LLC]4Current NDC, Legacy NDC, 2 package rows20250117_919cbd07-f587-4005-acff-26213dd1d1fb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197464clorazepate dipotassium 15 MG Oral TabletPSN919cbd07-f587-4005-acff-26213dd1d1fb5
197465clorazepate dipotassium 3.75 MG Oral TabletPSN919cbd07-f587-4005-acff-26213dd1d1fb5
197466clorazepate dipotassium 7.5 MG Oral TabletPSN919cbd07-f587-4005-acff-26213dd1d1fb5
197464clorazepate dipotassium 15 MG Oral TabletSCD919cbd07-f587-4005-acff-26213dd1d1fb5
197465clorazepate dipotassium 3.75 MG Oral TabletSCD919cbd07-f587-4005-acff-26213dd1d1fb5
197466clorazepate dipotassium 7.5 MG Oral TabletSCD919cbd07-f587-4005-acff-26213dd1d1fb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13107-319-0113107031901100 TABLET in 1 BOTTLE (13107-319-01) 100 tablet1987-07-172027-02-28NoNoCurrent
13107-319-0513107031905500 TABLET in 1 BOTTLE, PLASTIC (13107-319-05) 500 tablet1987-07-172027-02-28NoNoCurrent