Diazepam

Product NDC
0404-9848
11-digit product format
004049848
Labeler code
0404
Product ID
0404-9848_eb7ae780-68a5-4462-9822-3fe66678f967
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA071583
Marketing category
ANDA
Marketing start
2022-01-10
Marketing end
2026-12-31
Substance
DIAZEPAM
Active strength
5 mg/mL
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
Diazepam

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIAZEPAM5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui309845

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
0404-9848-10Diazepam1 in 1 BAGINJECTION, SOLUTION17
0404-9848-10Diazepam10 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION107

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-9848DIAZEPAM (DIAZEPAM) INJECTION, SOLUTION [HENRY SCHEIN, INC.]5Current NDC, Legacy NDC, 2 package rows20240727_bfa85a63-967f-4176-a752-0bafabbaaae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309845diazePAM 5 MG/ML Injectable SolutionPSNbfa85a63-967f-4176-a752-0bafabbaaae37
309845diazepam 5 MG/ML Injectable SolutionSCDbfa85a63-967f-4176-a752-0bafabbaaae37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0404-9848-10004049848101 VIAL, MULTI-DOSE in 1 BAG (0404-9848-10) / 10 mL in 1 VIAL, MULTI-DOSE2022-01-102026-12-31NoNoCurrent