FDA.reportPublic FDA data

Diazepam

Product NDC
21695-265
11-digit product format
216950265
Labeler code
21695
Product ID
21695-265_2d96a6cb-326f-4c04-b5d7-24d7f7c20699
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Rebel Distributors Corp.
Application
ANDA071322
Marketing category
ANDA
Marketing start
2009-11-09
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
10 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
21695-265-052019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-265-152019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-265-302019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-265-482019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-265-602019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only
21695-265-902019-09-24C16284748780-1934fe258-4bf3-48b1-e053-8cdaa90a720aDIAZEPAM TABLETS USP CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-265-05Diazepam5 in 1 BOTTLETABLET51
21695-265-15Diazepam15 in 1 BOTTLETABLET151
21695-265-30Diazepam30 in 1 BOTTLETABLET301
21695-265-48Diazepam48 in 1 BOTTLETABLET481
21695-265-60Diazepam60 in 1 BOTTLETABLET601
21695-265-90Diazepam90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-265-05EA - Each21695-26577ad6617-bcff-450e-bc23-d43640aaff3712012-07-24
21695-265-15EA - Each21695-265a22ad113-e096-43ce-a545-21221438154d12012-07-24
21695-265-30EA - Each21695-265386a9dc8-cbcb-4160-9a27-e67b7b7cea5212012-07-24
21695-265-60EA - Each21695-2652fd7b7d9-8b78-405c-821c-b605b5d6594612012-07-24
21695-265-90EA - Each21695-265ae309818-b831-4fba-90e6-ad44e786107912012-07-24

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
21695-265DIAZEPAM TABLET [REBEL DISTRIBUTORS CORP.]1Legacy NDC, 6 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
21695-265-05216950265055 in 1 BOTTLEHistorical
21695-265-152169502651515 in 1 BOTTLEHistorical
21695-265-302169502653030 in 1 BOTTLEHistorical
21695-265-482169502654848 in 1 BOTTLEHistorical
21695-265-602169502656060 in 1 BOTTLEHistorical
21695-265-902169502659090 in 1 BOTTLEHistorical