FDA.reportPublic FDA data

Diazepam

Product NDC
43353-783
11-digit product format
433530783
Labeler code
43353
Product ID
43353-783_32c4f44c-dd59-4b03-b271-6e51d20dbf75
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA077749
Marketing category
ANDA
Marketing start
2006-03-31
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43353-783-152020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-202020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-302020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-452020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-532020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-552020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-602020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-702020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-752020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-802020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
43353-783-902020-01-31C16284748780-19d75b9d0-4f66-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43353-783-15Diazepam15 in 1 BOTTLE, PLASTICTABLET152
43353-783-20Diazepam20 in 1 BOTTLE, PLASTICTABLET202
43353-783-30Diazepam30 in 1 BOTTLE, PLASTICTABLET302
43353-783-45Diazepam45 in 1 BOTTLE, PLASTICTABLET452
43353-783-53Diazepam60 in 1 BOTTLE, PLASTICTABLET602
43353-783-55Diazepam75 in 1 BOTTLE, PLASTICTABLET752
43353-783-60Diazepam90 in 1 BOTTLE, PLASTICTABLET902
43353-783-70Diazepam120 in 1 BOTTLE, PLASTICTABLET1202
43353-783-75Diazepam150 in 1 BOTTLE, PLASTICTABLET1502
43353-783-80Diazepam180 in 1 BOTTLE, PLASTICTABLET1802
43353-783-90Diazepam240 in 1 BOTTLE, PLASTICTABLET2402

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-783DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC, 11 package rows20140416_1a21e393-2dd5-4c64-b5a9-f29c28453edd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197590diazePAM 2 MG Oral TabletPSN1a21e393-2dd5-4c64-b5a9-f29c28453edd2
197591diazePAM 5 MG Oral TabletPSN1a21e393-2dd5-4c64-b5a9-f29c28453edd2
197590diazepam 2 MG Oral TabletSCD1a21e393-2dd5-4c64-b5a9-f29c28453edd2
197591diazepam 5 MG Oral TabletSCD1a21e393-2dd5-4c64-b5a9-f29c28453edd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
43353-783-154335307831515 in 1 BOTTLE, PLASTICHistorical
43353-783-204335307832020 in 1 BOTTLE, PLASTICHistorical
43353-783-304335307833030 in 1 BOTTLE, PLASTICHistorical
43353-783-454335307834545 in 1 BOTTLE, PLASTICHistorical
43353-783-534335307835360 in 1 BOTTLE, PLASTICHistorical
43353-783-554335307835575 in 1 BOTTLE, PLASTICHistorical
43353-783-604335307836090 in 1 BOTTLE, PLASTICHistorical
43353-783-7043353078370120 in 1 BOTTLE, PLASTICHistorical
43353-783-7543353078375150 in 1 BOTTLE, PLASTICHistorical
43353-783-8043353078380180 in 1 BOTTLE, PLASTICHistorical
43353-783-9043353078390240 in 1 BOTTLE, PLASTICHistorical