Diazepam

Product NDC
53217-185
11-digit product format
532170185
Labeler code
53217
Product ID
53217-185_7030384d-e301-4908-b923-e823795e9e80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071322
Marketing category
ANDA
Marketing start
1986-12-10
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
53217-185-002020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-022020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-052020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-072020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-082020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-102020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-142020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-202020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-292020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-302020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-312020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-602020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927
53217-185-902020-01-31C16284748780-19d75b9cf-fdac-f424-e053-dadaa90a57ceDIAZEPAM TABLETS USP CIV 3925 3926 3927

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-185-00Diazepam100 in 1 BOTTLETABLET1006
53217-185-02Diazepam120 in 1 BOTTLETABLET1206
53217-185-05Diazepam5 in 1 BOTTLETABLET56
53217-185-07Diazepam7 in 1 BOTTLETABLET76
53217-185-08Diazepam8 in 1 BOTTLETABLET86
53217-185-10Diazepam10 in 1 BOTTLETABLET106
53217-185-14Diazepam14 in 1 BOTTLETABLET146
53217-185-20Diazepam20 in 1 BOTTLETABLET206
53217-185-29Diazepam2 in 1 BOTTLETABLET26
53217-185-30Diazepam30 in 1 BOTTLETABLET306
53217-185-31Diazepam3 in 1 BOTTLETABLET36
53217-185-60Diazepam60 in 1 BOTTLETABLET606
53217-185-90Diazepam90 in 1 BOTTLETABLET906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-185-00EA - Each53217-185dbc837b7-d092-402b-99d8-c0e186ce5a9b12017-03-06
53217-185-02EA - Each53217-185be30c457-123b-448f-b91e-b01f2f12fdac12017-03-06
53217-185-05EA - Each53217-185253ff70d-2fdb-4769-be70-ac82cfe285b812017-03-06
53217-185-07EA - Each53217-1855b09bf98-4e58-4cfb-a45f-9d4020a430e912017-03-06
53217-185-08EA - Each53217-185e2fd58f7-1871-4764-8bf7-819bd0a4f67212017-03-06
53217-185-10EA - Each53217-18524507018-06bc-4761-af6b-5017115c52de12017-03-06
53217-185-14EA - Each53217-18589af3593-fe64-4494-a35f-f4bfa7efe1c212017-03-06
53217-185-20EA - Each53217-185c4568732-e267-4041-a27a-7a1fff1ea55b12017-03-06
53217-185-29EA - Each53217-18590910569-ac5d-4858-843a-f4c8a46796b612017-03-06
53217-185-30EA - Each53217-185f73f005b-6be4-4ba3-9b65-b93051876b7d12017-03-06
53217-185-31EA - Each53217-185f7ca4998-0748-4bd4-ac5e-52f62f675a2012017-03-06
53217-185-60EA - Each53217-18547bba081-d920-4504-8790-813c26b96cae12017-03-06
53217-185-90EA - Each53217-185dda71f3b-de6e-44a0-83b6-e7c9b68c25a312017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-185DIAZEPAM 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
53217-185-0053217018500100 in 1 BOTTLEHistorical
53217-185-0253217018502120 in 1 BOTTLEHistorical
53217-185-05532170185055 in 1 BOTTLEHistorical
53217-185-07532170185077 in 1 BOTTLEHistorical
53217-185-08532170185088 in 1 BOTTLEHistorical
53217-185-105321701851010 in 1 BOTTLEHistorical
53217-185-145321701851414 in 1 BOTTLEHistorical
53217-185-205321701852020 in 1 BOTTLEHistorical
53217-185-29532170185292 in 1 BOTTLEHistorical
53217-185-305321701853030 in 1 BOTTLEHistorical
53217-185-31532170185313 in 1 BOTTLEHistorical
53217-185-605321701856060 in 1 BOTTLEHistorical
53217-185-905321701859090 in 1 BOTTLEHistorical