FDA.reportPublic FDA data

Diazepam

Product NDC
67296-1349
11-digit product format
672961349
Labeler code
67296
Product ID
67296-1349_9c9f7825-f328-4acd-e053-2995a90af8f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
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
2021-12-31
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
67296-1349-12022-01-28C16284748780-1d6a99b39-3707-a426-e053-dadaa90af4c250377b7a-6fb4-43f2-e054-00144ff8d46c
67296-1349-22022-01-28C16284748780-1d6a99b39-3707-a426-e053-dadaa90af4c250377b7a-6fb4-43f2-e054-00144ff8d46c
67296-1349-52022-01-28C16284748780-1d6a99b39-3707-a426-e053-dadaa90af4c250377b7a-6fb4-43f2-e054-00144ff8d46c
67296-1349-62022-01-28C16284748780-1d6a99b39-3707-a426-e053-dadaa90af4c250377b7a-6fb4-43f2-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1349-1Diazepam10 in 1 BOTTLETABLET102
67296-1349-2Diazepam20 in 1 BOTTLETABLET202
67296-1349-5Diazepam15 in 1 BOTTLETABLET152
67296-1349-6Diazepam6 in 1 BOTTLETABLET62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1349DIAZEPAM TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 4 package rows20200121_50377b7a-6fb4-43f2-e054-00144ff8d46c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN50377b7a-6fb4-43f2-e054-00144ff8d46c2
197591diazepam 5 MG Oral TabletSCD50377b7a-6fb4-43f2-e054-00144ff8d46c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1349-16729613490110 TABLET in 1 BOTTLE (67296-1349-1) 10 tablet2016-08-030000-00-00NoNoCurrent
67296-1349-26729613490220 TABLET in 1 BOTTLE (67296-1349-2) 20 tablet2016-08-030000-00-00NoNoCurrent
67296-1349-56729613490515 TABLET in 1 BOTTLE (67296-1349-5) 15 tablet2016-08-030000-00-00NoNoCurrent
67296-1349-6672961349066 TABLET in 1 BOTTLE (67296-1349-6) 6 tablet2016-08-030000-00-00NoNoCurrent