FDA.reportPublic FDA data

DIAZEPAM

Product NDC
61919-071
11-digit product format
619190071
Labeler code
61919
Product ID
61919-071_9238dcea-d909-c1e3-e053-2a95a90aeef9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
DIRECT RX
Application
ANDA077749
Marketing category
ANDA
Marketing start
2014-01-01
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
2020-12-31
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
61919-071-102023-01-30C16284748780-1f386c649-c329-0266-e053-dadaa90a7c1aDIAZEPAM
61919-071-302023-01-30C16284748780-1f386c649-c329-0266-e053-dadaa90a7c1aDIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-071-10DIAZEPAM10 in 1 BOTTLETABLET104
61919-071-20DIAZEPAM20 in 1 BOTTLETABLET204
61919-071-30DIAZEPAM30 in 1 BOTTLETABLET304
61919-071-60DIAZEPAM60 in 1 BOTTLETABLET604

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-071-20EA - Each61919-0715419f074-ea02-4ce2-af60-f474d9eb1de912015-10-02
61919-071-30EA - Each61919-071855e2841-b6f8-4d1c-97ac-98a7ecefc09412015-10-02
61919-071-60EA - Each61919-0712824df01-89f7-4fc1-9cf1-63ccd5ce5ef312015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]2
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]2
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [DIRECT RX]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [DIRECT RX]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [DIRECT RX]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [DIRECT RX]2
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [DIRECT RX]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [DIRECT RX]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-071DIAZEPAM TABLET [DIRECT RX]4Legacy NDC, 4 package rows20190911_0952dd80-819c-424e-9a82-eb161c02af4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN0952dd80-819c-424e-9a82-eb161c02af4d4
197589diazepam 10 MG Oral TabletSCD0952dd80-819c-424e-9a82-eb161c02af4d4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-071-106191900711010 TABLET in 1 BOTTLE (61919-071-10) 10 tablet2014-01-010000-00-00NoNoCurrent
61919-071-206191900712020 in 1 BOTTLEHistorical
61919-071-306191900713030 BOTTLE in 1 BOTTLE (61919-071-30) > 20 BOTTLE in 1 BOTTLE (61919-071-20) > 60 TABLET in 1 BOTTLE (61919-071-60) 30 bottle2019-09-100000-00-00NoNoCurrent
61919-071-606191900716060 in 1 BOTTLEHistorical