DIAZEPAM

Product NDC
59651-653
11-digit product format
596510653
Labeler code
59651
Product ID
59651-653_2f799120-0d08-47cd-8183-a98f0267c845
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA217843
Marketing category
ANDA
Marketing start
2023-12-14
Substance
DIAZEPAM
Active strength
5 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
DIAZEPAM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 197590, 197591

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
69057c52-36b0-21c0-02d6-d697be15c03cProduct name420260305
da74e203-d183-4c62-8511-c3ef56b5964eProduct name120250213
2792dd44-ff30-4712-8b05-1850c2b4d307Product name320250211
2fd3ebb9-86c1-64e3-e9b6-3c2ba01c6876Product name220250102
0f898f8b-23f1-b816-6bfe-c7f8aac7e42bProduct name220240529
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-653-01DIAZEPAM100 in 1 BOTTLETABLET1001
59651-653-05DIAZEPAM500 in 1 BOTTLETABLET5001
59651-653-99DIAZEPAM1000 in 1 BOTTLETABLET10001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-653-01EA - Each59651-6534c3dd6d8-c448-4ecb-8a35-5955d63df21e12024-04-05
59651-653-05EA - Each59651-653c4c74633-71f4-4715-b1f1-6a98735137cf12024-04-05
59651-653-99EA - Each59651-65361672fed-109d-4835-8c62-fec86d99ae5012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-653DIAZEPAM TABLET [AUROBINDO PHARMA LIMITED]1Current NDC, 3 package rows20231219_2f799120-0d08-47cd-8183-a98f0267c845.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN21785bb2-cc96-7973-e063-6294a90ab1b83
197591diazepam 5 MG Oral TabletSCD21785bb2-cc96-7973-e063-6294a90ab1b83
197591diazePAM 5 MG Oral TabletPSN22688087-27ad-620c-e063-6394a90a134c2
197591diazepam 5 MG Oral TabletSCD22688087-27ad-620c-e063-6394a90a134c2
197589diazePAM 10 MG Oral TabletPSN2f799120-0d08-47cd-8183-a98f0267c8451
197589diazePAM 10 MG Oral TabletPSN426f3da1-4105-ba0a-e063-6294a90a7a861
197590diazePAM 2 MG Oral TabletPSN2f799120-0d08-47cd-8183-a98f0267c8451
197590diazePAM 2 MG Oral TabletPSN426f3da1-4105-ba0a-e063-6294a90a7a861
197591diazePAM 5 MG Oral TabletPSN2f799120-0d08-47cd-8183-a98f0267c8451
197591diazePAM 5 MG Oral TabletPSN426f3da1-4105-ba0a-e063-6294a90a7a861
197589diazepam 10 MG Oral TabletSCD2f799120-0d08-47cd-8183-a98f0267c8451
197589diazepam 10 MG Oral TabletSCD426f3da1-4105-ba0a-e063-6294a90a7a861
197590diazepam 2 MG Oral TabletSCD2f799120-0d08-47cd-8183-a98f0267c8451
197590diazepam 2 MG Oral TabletSCD426f3da1-4105-ba0a-e063-6294a90a7a861
197591diazepam 5 MG Oral TabletSCD2f799120-0d08-47cd-8183-a98f0267c8451
197591diazepam 5 MG Oral TabletSCD426f3da1-4105-ba0a-e063-6294a90a7a861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
59651-653-0159651065301100 TABLET in 1 BOTTLE (59651-653-01) 100 tablet2023-12-14NoNoCurrent
59651-653-0559651065305500 TABLET in 1 BOTTLE (59651-653-05) 500 tablet2023-12-14NoNoCurrent
59651-653-99596510653991000 TABLET in 1 BOTTLE (59651-653-99) 1000 tablet2023-12-14NoNoCurrent