FDA.reportPublic FDA data

CLORAZEPATE DIPOTASSIUM

Product NDC
13107-320
11-digit product format
131070320
Labeler code
13107
Product ID
13107-320_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
7.5 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 DIPOTASSIUM7.5 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
13107-320-01CLORAZEPATE DIPOTASSIUM100 in 1 BOTTLE, PLASTICTABLET1005
13107-320-05CLORAZEPATE DIPOTASSIUM500 in 1 BOTTLE, PLASTICTABLET5005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13107-320-01EA - Each13107-3205ac42a17-088e-4c49-9506-25c4450e235312021-12-08
13107-320-05EA - Each13107-3202d5e012d-4e34-45e5-956a-5c137f4cb22b12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-320CLORAZEPATE 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
13107-320-0113107032001100 TABLET in 1 BOTTLE, PLASTIC (13107-320-01) 100 tablet1987-07-172027-02-28NoNoCurrent
13107-320-0513107032005500 TABLET in 1 BOTTLE, PLASTIC (13107-320-05) 500 tablet1987-07-172027-02-28NoNoCurrent