FDA.reportPublic FDA data

DIAZEPAM

Product NDC
52959-306
11-digit product format
529590306
Labeler code
52959
Product ID
52959-306_75c7d502-0179-5ba1-e053-2a91aa0a7d67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
H.J. Harkins Company, Inc.
Application
ANDA071136
Marketing category
ANDA
Marketing start
2016-01-25
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
10 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
52959-306-002020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-012020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-022020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-052020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-062020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-102020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-142020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-152020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-202020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-282020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-302020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-452020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-602020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM
52959-306-902020-01-31C16284748780-19d75b9cf-e015-f424-e053-dadaa90a57ce0047/0295/0306 DIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52959-306-00DIAZEPAM100 in 1 BOTTLETABLET1001
52959-306-01DIAZEPAM2 in 1 BOTTLETABLET21
52959-306-02DIAZEPAM120 in 1 BOTTLETABLET1201
52959-306-05DIAZEPAM5 in 1 BOTTLETABLET51
52959-306-06DIAZEPAM6 in 1 BOTTLETABLET61
52959-306-10DIAZEPAM10 in 1 BOTTLETABLET101
52959-306-14DIAZEPAM14 in 1 BOTTLETABLET141
52959-306-15DIAZEPAM15 in 1 BOTTLETABLET151
52959-306-20DIAZEPAM20 in 1 BOTTLETABLET201
52959-306-28DIAZEPAM28 in 1 BOTTLETABLET281
52959-306-30DIAZEPAM30 in 1 BOTTLETABLET301
52959-306-45DIAZEPAM45 in 1 BOTTLETABLET451
52959-306-60DIAZEPAM60 in 1 BOTTLETABLET601
52959-306-90DIAZEPAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52959-306-00EA - Each52959-306b964b169-1ee5-44e9-93cb-11dd78552f3612018-10-11
52959-306-02EA - Each52959-3067970ff60-25d7-44af-bde1-aeb4df689dd012018-10-11
52959-306-05EA - Each52959-306fa2e10b0-d4c8-423c-8c55-e463d747d65e12018-10-11
52959-306-06EA - Each52959-306422420f3-88e1-4fdf-b472-448ff0ce1b2512018-10-11
52959-306-10EA - Each52959-306d64113d2-c491-4d33-99ed-9f1e0837076d12018-10-11
52959-306-15EA - Each52959-306a11408d7-93f5-4a7e-9222-c02e4aaead0f12018-10-11
52959-306-20EA - Each52959-3069ecc1e1c-fee4-4590-b4ae-087abffbd7ee12018-10-11
52959-306-28EA - Each52959-30677103a34-7080-4eab-9132-05991557922912018-10-11
52959-306-30EA - Each52959-306a68af343-31db-4bea-9260-b6ec328d0be112018-10-11
52959-306-45EA - Each52959-3063da64e9a-210b-4a95-aa70-97608fcf09f312018-10-11
52959-306-60EA - Each52959-30675fc6917-49fb-49c5-9717-2d988e577f5212018-10-11
52959-306-90EA - Each52959-306875a9bd2-ffbf-4c10-b6a4-d05a6a6326d712018-10-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52959-306DIAZEPAM TABLET [H.J. HARKINS COMPANY, INC.]1Legacy NDC, 14 package rows20180926_75c7d502-0178-5ba1-e053-2a91aa0a7d67.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197590diazePAM 2 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197591diazePAM 5 MG Oral TabletPSN75c7d502-0178-5ba1-e053-2a91aa0a7d671
197589diazepam 10 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671
197590diazepam 2 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671
197591diazepam 5 MG Oral TabletSCD75c7d502-0178-5ba1-e053-2a91aa0a7d671

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
52959-306-0052959030600100 in 1 BOTTLEHistorical
52959-306-01529590306012 in 1 BOTTLEHistorical
52959-306-0252959030602120 in 1 BOTTLEHistorical
52959-306-05529590306055 in 1 BOTTLEHistorical
52959-306-06529590306066 in 1 BOTTLEHistorical
52959-306-105295903061010 in 1 BOTTLEHistorical
52959-306-145295903061414 in 1 BOTTLEHistorical
52959-306-155295903061515 in 1 BOTTLEHistorical
52959-306-205295903062020 in 1 BOTTLEHistorical
52959-306-285295903062828 in 1 BOTTLEHistorical
52959-306-305295903063030 in 1 BOTTLEHistorical
52959-306-455295903064545 in 1 BOTTLEHistorical
52959-306-605295903066060 in 1 BOTTLEHistorical
52959-306-905295903069090 in 1 BOTTLEHistorical