FDA.reportPublic FDA data

DIAZEPAM

Product NDC
61919-906
11-digit product format
619190906
Labeler code
61919
Product ID
61919-906_47e14ab4-5eb5-67c7-e063-6394a90a1e4b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
Direct_Rx
Application
ANDA071322
Marketing category
ANDA
Marketing start
2016-11-01
Substance
DIAZEPAM
Active strength
10 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
DIAZEPAM10 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-906-02DIAZEPAM2 in 1 BOTTLETABLET218
61919-906-05DIAZEPAM5 in 1 BOTTLETABLET518
61919-906-10DIAZEPAM10 in 1 BOTTLETABLET1018
61919-906-30DIAZEPAM30 in 1 BOTTLETABLET3018
61919-906-60DIAZEPAM60 in 1 BOTTLETABLET6018
61919-906-90DIAZEPAM90 in 1 BOTTLETABLET9018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-906-02EA - Each61919-90665f3d627-1a95-4c17-8bf0-8c0058c933e812024-10-04
61919-906-05EA - Each61919-906b58e272c-5e32-4de1-9c7e-a75d8e35323112019-08-06
61919-906-10EA - Each61919-9068a38157c-0f05-4faa-970d-cf6758f4893d12019-12-10
61919-906-30EA - Each61919-9064a32046b-a190-4d37-982a-3e333cb7114a12019-12-10
61919-906-60EA - Each61919-9062acd2fbc-07a9-46d2-ab5e-803109a5355212022-03-09

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
61919-906DIAZEPAM TABLET [DIRECT_RX]17Current NDC, Legacy NDC, 6 package rows20240920_4b0c9c0a-4274-4d56-a7a4-bc497916469c.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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-906-02619190906022 TABLET in 1 BOTTLE (61919-906-02) 2 tablet2016-11-01NoNoCurrent
61919-906-05619190906055 TABLET in 1 BOTTLE (61919-906-05) 5 tablet2019-09-250000-00-00NoNoCurrent
61919-906-106191909061010 TABLET in 1 BOTTLE (61919-906-10) 10 tablet2016-11-010000-00-00NoNoCurrent
61919-906-306191909063030 TABLET in 1 BOTTLE (61919-906-30) 30 tablet2016-11-010000-00-00NoNoCurrent
61919-906-606191909066060 TABLET in 1 BOTTLE (61919-906-60) 60 tablet2016-11-010000-00-00NoNoCurrent
61919-906-906191909069090 TABLET in 1 BOTTLE (61919-906-90) 90 tablet2016-11-010000-00-00NoNoCurrent