Diazepam

Product NDC
43353-825
11-digit product format
433530825
Labeler code
43353
Product ID
43353-825_ab1a1c72-dcae-47ba-8f0e-aefb9b5143a0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071307
Marketing category
ANDA
Marketing start
1986-12-10
Substance
DIAZEPAM
Active strength
2 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
DIAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197590

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
43353-825-30Diazepam30 in 1 BOTTLETABLET301
43353-825-53Diazepam60 in 1 BOTTLETABLET601
43353-825-60Diazepam90 in 1 BOTTLETABLET901
43353-825-70Diazepam120 in 1 BOTTLETABLET1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-825DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Current NDC, Legacy NDC, 4 package rows20171208_b29916fb-1781-4112-9c3e-45478754d638.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197590diazePAM 2 MG Oral TabletPSNb29916fb-1781-4112-9c3e-45478754d6381
197590diazepam 2 MG Oral TabletSCDb29916fb-1781-4112-9c3e-45478754d6381

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-825-304335308253030 TABLET in 1 BOTTLE (43353-825-30) 30 tablet2013-03-080000-00-00NoNoCurrent
43353-825-534335308255360 TABLET in 1 BOTTLE (43353-825-53) 60 tablet2013-03-080000-00-00NoNoCurrent
43353-825-604335308256090 TABLET in 1 BOTTLE (43353-825-60) 90 tablet2013-03-080000-00-00NoNoCurrent
43353-825-7043353082570120 TABLET in 1 BOTTLE (43353-825-70) 120 tablet2013-03-080000-00-00NoNoCurrent