FDA.reportPublic FDA data

DIAZEPAM

Product NDC
61919-409
11-digit product format
619190409
Labeler code
61919
Product ID
61919-409_47e14ab4-5eb5-67c7-e063-6394a90a1e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA071321
Marketing category
ANDA
Marketing start
2019-11-18
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
DIAZEPAM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 197591

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
61919-409-302025-01-30C16284748780-12cef2736-6f8f-d83d-e063-dadaa90ab31fDIAZEPAM
61919-409-602025-01-30C16284748780-12cef2736-83e4-d83d-e063-dadaa90ab31fDIAZEPAM
61919-409-722025-01-30C16284748780-12cef2736-6f8f-d83d-e063-dadaa90ab31fDIAZEPAM
61919-409-032023-01-30C16284748780-1f386c649-cac0-0266-e053-dadaa90a7c1aDIAZEPAM
61919-409-102023-01-30C16284748780-1f386c64a-43d5-0266-e053-dadaa90a7c1aDIAZEPAM
61919-409-902023-01-30C16284748780-1f386c649-ec4a-0266-e053-dadaa90a7c1aDIAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-409-02DIAZEPAM2 in 1 BOTTLETABLET218
61919-409-30DIAZEPAM30 in 1 BOTTLETABLET303
61919-409-60DIAZEPAM60 in 1 BOTTLETABLET603
61919-409-72DIAZEPAM120 in 1 BOTTLETABLET1203
61919-409-03DIAZEPAM3 in 1 BOTTLETABLET31
61919-409-10DIAZEPAM10 in 1 BOTTLETABLET101
61919-409-90DIAZEPAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-409-02EA - Each61919-40923cac476-b637-4751-873a-d2ce913c555912019-12-10
61919-409-03EA - Each61919-409f21e6233-bd01-4ca3-b4cc-d3affe5f69f812019-09-05
61919-409-10EA - Each61919-40977ca266c-f167-426e-969b-293d95b4ac8212019-08-06
61919-409-30EA - Each61919-4097fc4143e-80c9-471f-a83a-34f05ef4b21012019-08-06
61919-409-60EA - Each61919-409a1d88be3-8b27-4275-a831-54c6a96f662612021-05-05
61919-409-72EA - Each61919-4097be766ac-874b-49a6-9c9a-3f3c721de66412019-09-05
61919-409-90EA - Each61919-409727e3d9d-141b-4b5d-9918-c5468d23142312019-08-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [DIRECT RX]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [DIRECT RX]1
GALACTOSE MONOHYDRATEINACTIVE INGREDIENT2C22T7DYYRDIAZEPAM TABLET [DIRECT RX]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-409DIAZEPAM TABLET [DIRECT_RX]17Current NDC, Legacy NDC, 1 package rows20240920_4b0c9c0a-4274-4d56-a7a4-bc497916469c.zip
61919-409DIAZEPAM TABLET [DIRECT_RX]3Current NDC, Legacy NDC, 1 package rows20230421_8d68919b-6909-7618-e053-2a95a90a7b6a.zip
61919-409DIAZEPAM TABLET [DIRECT_RX]3Current NDC, Legacy NDC, 2 package rows20230113_8d6938a4-4659-6520-e053-2995a90a5872.zip
61919-409DIAZEPAM TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190703_8c3ea014-0015-09f3-e053-2a95a90ac16d.zip
61919-409DIAZEPAM TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190712_8d67f5f8-994f-83a9-e053-2995a90abda4.zip
61919-409DIAZEPAM TABLET [DIRECT_RX]1Current NDC, Legacy NDC, 1 package rows20190712_8d68414a-a7ea-a414-e053-2995a90af293.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN4b0c9c0a-4274-4d56-a7a4-bc497916469c18
197591diazePAM 5 MG Oral TabletPSN4b0c9c0a-4274-4d56-a7a4-bc497916469c18
197589diazepam 10 MG Oral TabletSCD4b0c9c0a-4274-4d56-a7a4-bc497916469c18
197591diazepam 5 MG Oral TabletSCD4b0c9c0a-4274-4d56-a7a4-bc497916469c18
197591diazePAM 5 MG Oral TabletPSN8d68919b-6909-7618-e053-2a95a90a7b6a3
197591diazePAM 5 MG Oral TabletPSN8d6938a4-4659-6520-e053-2995a90a58723
197591diazepam 5 MG Oral TabletSCD8d68919b-6909-7618-e053-2a95a90a7b6a3
197591diazepam 5 MG Oral TabletSCD8d6938a4-4659-6520-e053-2995a90a58723
197591diazePAM 5 MG Oral TabletPSN8c3ea014-0015-09f3-e053-2a95a90ac16d1
197591diazePAM 5 MG Oral TabletPSN8d67f5f8-994f-83a9-e053-2995a90abda41
197591diazePAM 5 MG Oral TabletPSN8d68414a-a7ea-a414-e053-2995a90af2931
197591diazepam 5 MG Oral TabletSCD8c3ea014-0015-09f3-e053-2a95a90ac16d1
197591diazepam 5 MG Oral TabletSCD8d67f5f8-994f-83a9-e053-2995a90abda41
197591diazepam 5 MG Oral TabletSCD8d68414a-a7ea-a414-e053-2995a90af2931

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-409-02619190409022 TABLET in 1 BOTTLE (61919-409-02) 2 tablet2019-11-180000-00-00NoNoCurrent
61919-409-03619190409033 TABLET in 1 BOTTLE (61919-409-03) 3 tablet2019-07-110000-00-00NoNoCurrent
61919-409-106191904091010 TABLET in 1 BOTTLE (61919-409-10) 10 tablet2019-07-110000-00-00NoNoCurrent
61919-409-306191904093030 TABLET in 1 BOTTLE (61919-409-30) 30 tablet2019-07-110000-00-00NoNoCurrent
61919-409-606191904096060 TABLET in 1 BOTTLE (61919-409-60) 60 tablet2019-07-110000-00-00NoNoCurrent
61919-409-7261919040972120 TABLET in 1 BOTTLE (61919-409-72) 120 tablet2019-07-110000-00-00NoNoCurrent
61919-409-906191904099090 TABLET in 1 BOTTLE (61919-409-90) 90 tablet2019-06-260000-00-00NoNoCurrent