FDA.reportPublic FDA data

Diazepam

Product NDC
21695-264
11-digit product format
216950264
Labeler code
21695
Product ID
21695-264_2d96a6cb-326f-4c04-b5d7-24d7f7c20699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA071321
Marketing category
ANDA
Marketing start
2009-11-09
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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
21695-264-022019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-102019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-122019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-152019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-202019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-302019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-452019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-602019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-264-902019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-264-02Diazepam2 in 1 BOTTLETABLET21
21695-264-10Diazepam10 in 1 BOTTLETABLET101
21695-264-12Diazepam12 in 1 BOTTLETABLET121
21695-264-15Diazepam15 in 1 BOTTLETABLET151
21695-264-20Diazepam20 in 1 BOTTLETABLET201
21695-264-30Diazepam30 in 1 BOTTLETABLET301
21695-264-45Diazepam45 in 1 BOTTLETABLET451
21695-264-60Diazepam60 in 1 BOTTLETABLET601
21695-264-90Diazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-264-02EA - Each21695-26466defdd1-3088-4d9d-bfc2-0763653c3b5b12012-07-24
21695-264-10EA - Each21695-264b3a479f2-7c98-4cf7-9f19-46ed478b42bd12012-07-24
21695-264-12EA - Each21695-26403f39246-ba2a-4d2f-bcdd-39b41fcf6e8412012-07-24
21695-264-15EA - Each21695-2646b126895-540f-453d-b37d-a6edd5ad246112012-07-24
21695-264-20EA - Each21695-26470ee587b-e79e-453c-aaed-6ae32ee3092d12012-07-24
21695-264-30EA - Each21695-264ae4984bf-d7f3-468c-8c09-c5e7de4a12ce12012-07-24
21695-264-45EA - Each21695-264c0d5ddf1-ea2a-430e-a9b2-946facc2fc5712012-07-24
21695-264-60EA - Each21695-264b135cfef-83a0-4764-a1b1-aa02992f619712012-07-24
21695-264-90EA - Each21695-264b79b26ac-6b09-43e1-82b4-fbf145ca3c9312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DiazepamACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
DiazepamACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
COLLOIDAL SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-264DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 9 package rows20100921_2d96a6cb-326f-4c04-b5d7-24d7f7c20699.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN2d96a6cb-326f-4c04-b5d7-24d7f7c206991
197590diazePAM 2 MG Oral TabletPSN2d96a6cb-326f-4c04-b5d7-24d7f7c206991
197591diazePAM 5 MG Oral TabletPSN2d96a6cb-326f-4c04-b5d7-24d7f7c206991
197589diazepam 10 MG Oral TabletSCD2d96a6cb-326f-4c04-b5d7-24d7f7c206991
197590diazepam 2 MG Oral TabletSCD2d96a6cb-326f-4c04-b5d7-24d7f7c206991
197591diazepam 5 MG Oral TabletSCD2d96a6cb-326f-4c04-b5d7-24d7f7c206991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-264-02216950264022 in 1 BOTTLEHistorical
21695-264-102169502641010 in 1 BOTTLEHistorical
21695-264-122169502641212 in 1 BOTTLEHistorical
21695-264-152169502641515 in 1 BOTTLEHistorical
21695-264-202169502642020 in 1 BOTTLEHistorical
21695-264-302169502643030 in 1 BOTTLEHistorical
21695-264-452169502644545 in 1 BOTTLEHistorical
21695-264-602169502646060 in 1 BOTTLEHistorical
21695-264-902169502649090 in 1 BOTTLEHistorical