Diazepam

Product NDC
45865-482
11-digit product format
458650482
Labeler code
45865
Product ID
45865-482_718c0dfc-15fa-92e0-e053-2995a90a3051
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Medsource Pharmaceuticals
Application
ANDA071135
Marketing category
ANDA
Marketing start
2016-08-03
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
2020-12-31
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
45865-482-302025-01-30C16284748780-12cef2736-844c-d83d-e063-dadaa90ab31fDiazepam Tablets USP C-IV
45865-482-602025-01-30C16284748780-12cef2736-844c-d83d-e063-dadaa90ab31fDiazepam Tablets USP C-IV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
45865-482-30Diazepam30 in 1 BOTTLE, PLASTICTABLET303
45865-482-60Diazepam60 in 1 BOTTLE, PLASTICTABLET603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45865-482DIAZEPAM TABLET [MEDSOURCE PHARMACEUTICALS]3Legacy NDC, 2 package rows20180725_718c0dfc-15f9-92e0-e053-2995a90a3051.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN718c0dfc-15f9-92e0-e053-2995a90a30513
197591diazepam 5 MG Oral TabletSCD718c0dfc-15f9-92e0-e053-2995a90a30513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45865-482-304586504823030 TABLET in 1 BOTTLE, PLASTIC (45865-482-30) 30 tablet2018-01-010000-00-00NoNoCurrent
45865-482-604586504826060 TABLET in 1 BOTTLE, PLASTIC (45865-482-60) 60 tablet2018-01-010000-00-00NoNoCurrent