FDA.reportPublic FDA data

Diazepam

Product NDC
51079-284
11-digit product format
510790284
Labeler code
51079
Product ID
51079-284_3a39f676-7a52-3d33-e063-6294a90a4123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Mylan Institutional Inc.
Application
ANDA070325
Marketing category
ANDA
Marketing start
1997-10-31
Substance
DIAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 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
51079-284-01Diazepam1 in 1 BLISTER PACKTABLET118
51079-284-20Diazepam100 in 1 CARTONTABLET10018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51079-284-01EA - Each51079-2845a21e470-357c-4ce0-8908-598847b8391312012-07-24
51079-284-20EA - Each51079-284b241accc-c7a7-4424-ac8e-a33db2e433dd12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51079-284DIAZEPAM TABLET [MYLAN INSTITUTIONAL INC.]17Current NDC, Legacy NDC, 2 package rows20240919_b326c66d-5762-4d16-933c-619fa2088ccd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197590diazePAM 2 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197591diazePAM 5 MG Oral TabletPSNb326c66d-5762-4d16-933c-619fa2088ccd18
197589diazepam 10 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18
197590diazepam 2 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18
197591diazepam 5 MG Oral TabletSCDb326c66d-5762-4d16-933c-619fa2088ccd18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51079-284-01510790284011 in 1 BLISTER PACKHistorical
51079-284-2051079028420100 BLISTER PACK in 1 CARTON (51079-284-20) / 1 TABLET in 1 BLISTER PACK (51079-284-01) 100 blister pack1997-10-310000-00-00NoNoCurrent