FDA.reportPublic FDA data

Diazepam

Product NDC
61919-367
11-digit product format
619190367
Labeler code
61919
Product ID
61919-367_aec04fa3-6bdb-4c8a-be28-b47cae51a286
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Direct Rx
Application
ANDA071135
Marketing category
ANDA
Marketing start
2015-01-01
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
61919-367-302020-01-31C16284748780-19d75b9d0-ac3f-f424-e053-dadaa90a57ceDiazepam
61919-367-602020-01-31C16284748780-19d75b9d0-ac3f-f424-e053-dadaa90a57ceDiazepam
61919-367-902020-01-31C16284748780-19d75b9d0-ac3f-f424-e053-dadaa90a57ceDiazepam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-367-30Diazepam30 in 1 BOTTLETABLET303
61919-367-60Diazepam60 in 1 BOTTLETABLET603
61919-367-90Diazepam90 in 1 BOTTLETABLET903

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-367-30EA - Each61919-36727b03ddb-d4cc-49f5-81e5-efc2e7c88d4112016-09-02
61919-367-60EA - Each61919-3672edfb98c-e2fd-4886-bb31-4d682b39844712016-09-02
61919-367-90EA - Each61919-36709a00ad7-8802-4868-a163-e07d5c1e3b6b12016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [DIRECT RX]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [DIRECT RX]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [DIRECT RX]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [DIRECT RX]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-367DIAZEPAM TABLET [DIRECT RX]3Legacy NDC, 3 package rows20151107_18f75616-f712-4e1e-a88e-93cdc6cd2f1f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN18f75616-f712-4e1e-a88e-93cdc6cd2f1f3
197591diazepam 5 MG Oral TabletSCD18f75616-f712-4e1e-a88e-93cdc6cd2f1f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-367-306191903673030 in 1 BOTTLEHistorical
61919-367-606191903676060 in 1 BOTTLEHistorical
61919-367-906191903679090 in 1 BOTTLEHistorical