Diazepam

Product NDC
58118-4047
11-digit product format
581184047
Labeler code
58118
Product ID
58118-4047_0e85c568-114e-e644-e063-6294a90a1a74
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Clinical Solutions Wholesale, LLC
Application
ANDA070325
Marketing category
ANDA
Marketing start
1985-09-04
Substance
DIAZEPAM
Active strength
10 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
DIAZEPAM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589

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
58118-4047-8Diazepam30 in 1 BLISTER PACKTABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58118-4047DIAZEPAM TABLET [CLINICAL SOLUTIONS WHOLESALE, LLC]2Current NDC, Legacy NDC, 1 package rows20240110_8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32
197589diazepam 10 MG Oral TabletSCD8b4946b3-ae6c-4174-bbd8-0b8ed2c8fdf32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58118-4047-85811840470830 TABLET in 1 BLISTER PACK (58118-4047-8) 30 tablet2021-10-130000-00-00NoNoCurrent