Diazepam

Product NDC
53217-184
11-digit product format
532170184
Labeler code
53217
Product ID
53217-184_7030384d-e301-4908-b923-e823795e9e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071321
Marketing category
ANDA
Marketing start
1986-12-10
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
53217-184-002020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-022020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-052020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-072020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-082020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-102020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-142020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-202020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-292020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-302020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-312020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-602020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-184-902020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-184-00Diazepam100 in 1 BOTTLETABLET1006
53217-184-02Diazepam120 in 1 BOTTLETABLET1206
53217-184-05Diazepam5 in 1 BOTTLETABLET56
53217-184-07Diazepam7 in 1 BOTTLETABLET76
53217-184-08Diazepam8 in 1 BOTTLETABLET86
53217-184-10Diazepam10 in 1 BOTTLETABLET106
53217-184-14Diazepam14 in 1 BOTTLETABLET146
53217-184-20Diazepam20 in 1 BOTTLETABLET206
53217-184-29Diazepam2 in 1 BOTTLETABLET26
53217-184-30Diazepam30 in 1 BOTTLETABLET306
53217-184-31Diazepam3 in 1 BOTTLETABLET36
53217-184-60Diazepam60 in 1 BOTTLETABLET606
53217-184-90Diazepam90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-184-00EA - Each53217-1846a7f0abc-7dbb-4d85-bb03-8ec9a43d71a812017-03-06
53217-184-02EA - Each53217-184df0eff47-60a9-4196-837e-6d304700150e12017-03-06
53217-184-05EA - Each53217-184af906479-8b77-4be9-a029-bf75ae6ff36512017-03-06
53217-184-07EA - Each53217-184a81a9bec-662b-4a5d-89c3-e77f92d0b08e12017-03-06
53217-184-08EA - Each53217-1846fd561b0-2e52-4b4e-b87c-a25f59e0174512017-03-06
53217-184-10EA - Each53217-18463e742cc-3b01-4004-8faf-c4be1f11fe6712017-03-06
53217-184-14EA - Each53217-184ccbf68f7-affe-4e7b-b222-f35b91080aeb12017-03-06
53217-184-20EA - Each53217-1840b5addc5-d201-4125-8317-d79078af22af12017-03-06
53217-184-29EA - Each53217-184b003b996-4e71-49a3-ba0a-221efddc0a4112017-03-06
53217-184-30EA - Each53217-18493fcac3f-215a-4642-bbd5-de37a99c8b1612017-03-06
53217-184-31EA - Each53217-184a891517e-0837-4d2f-aa9b-fafe4d2933a012017-03-06
53217-184-60EA - Each53217-184760cef79-0f74-44c8-997f-1114b38e93c912017-03-06
53217-184-90EA - Each53217-1847024c573-fce7-4fa2-b9c7-96fb3800145312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-184DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]6Legacy NDC, 13 package rows20170303_bc6b93b1-4612-4b6a-8c25-53a17cd494af.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNbc6b93b1-4612-4b6a-8c25-53a17cd494af6
197591diazePAM 5 MG Oral TabletPSNbc6b93b1-4612-4b6a-8c25-53a17cd494af6
197589diazepam 10 MG Oral TabletSCDbc6b93b1-4612-4b6a-8c25-53a17cd494af6
197591diazepam 5 MG Oral TabletSCDbc6b93b1-4612-4b6a-8c25-53a17cd494af6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-184-0053217018400100 in 1 BOTTLEHistorical
53217-184-0253217018402120 in 1 BOTTLEHistorical
53217-184-05532170184055 in 1 BOTTLEHistorical
53217-184-07532170184077 in 1 BOTTLEHistorical
53217-184-08532170184088 in 1 BOTTLEHistorical
53217-184-105321701841010 in 1 BOTTLEHistorical
53217-184-145321701841414 in 1 BOTTLEHistorical
53217-184-205321701842020 in 1 BOTTLEHistorical
53217-184-29532170184292 in 1 BOTTLEHistorical
53217-184-305321701843030 in 1 BOTTLEHistorical
53217-184-31532170184313 in 1 BOTTLEHistorical
53217-184-605321701846060 in 1 BOTTLEHistorical
53217-184-905321701849090 in 1 BOTTLEHistorical