FDA.reportPublic FDA data

Valium

Product NDC
0140-0004
11-digit product format
001400004
Labeler code
0140
Product ID
0140-0004_ea505cdb-6d89-4b8c-8007-ec5a5fe920ce
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Roche Laboratories Inc.
Application
NDA013263
Marketing category
NDA
Marketing start
1963-11-15
Marketing end
2027-08-10
Substance
DIAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Valium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui104699, 104700, 197590, 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
0140-0004-01Valium100 in 1 BOTTLE, PLASTICTABLET10021
0140-0004-01Valium1 in 1 CARTONTABLET121

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0140-0004-01EA - Each0140-000489c14622-30f2-4c2c-b634-42fc79ac677212012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
diazepamACTIVE INGREDIENTQ3JTX2Q7TUVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
diazepamACTIVE MOIETYQ3JTX2Q7TUVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
calcium stearateINACTIVE INGREDIENT776XM7047LVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
D&C Yellow No. 10INACTIVE INGREDIENT35SW5USQ3GVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
FD&C Blue No. 1INACTIVE INGREDIENTH3R47K3TBDVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
FD&C Yellow No. 6INACTIVE INGREDIENTH77VEI93A8VALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8
starch, cornINACTIVE INGREDIENTO8232NY3SJVALIUM (DIAZEPAM) TABLET [GENENTECH, INC.]8

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0140-0004VALIUM (DIAZEPAM) TABLET [ROCHE LABORATORIES INC.]20Current NDC, Legacy NDC, 2 package rows20250108_554baee5-b171-4452-a50a-41a0946f956c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197590diazePAM 2 MG Oral TabletPSN554baee5-b171-4452-a50a-41a0946f956c21
197591diazePAM 5 MG Oral TabletPSN554baee5-b171-4452-a50a-41a0946f956c21
104699Valium 2 MG Oral TabletPSN554baee5-b171-4452-a50a-41a0946f956c21
104700Valium 5 MG Oral TabletPSN554baee5-b171-4452-a50a-41a0946f956c21
104699diazepam 2 MG Oral Tablet [Valium]SBD554baee5-b171-4452-a50a-41a0946f956c21
104700diazepam 5 MG Oral Tablet [Valium]SBD554baee5-b171-4452-a50a-41a0946f956c21
197590diazepam 2 MG Oral TabletSCD554baee5-b171-4452-a50a-41a0946f956c21
197591diazepam 5 MG Oral TabletSCD554baee5-b171-4452-a50a-41a0946f956c21
104699Valium 2 MG Oral TabletSY554baee5-b171-4452-a50a-41a0946f956c21
104700Valium 5 MG Oral TabletSY554baee5-b171-4452-a50a-41a0946f956c21

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0140-0004-01001400004011 BOTTLE, PLASTIC in 1 CARTON (0140-0004-01) / 100 TABLET in 1 BOTTLE, PLASTIC1963-11-152027-08-10NoNoCurrent