DIAZEPAM

Product NDC
0404-9769
11-digit product format
004049769
Labeler code
0404
Product ID
0404-9769_fac39e0b-2b18-42c7-b8fd-41dbddd999e8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
INJECTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Henry Schein, Inc.
Application
ANDA070313
Marketing category
ANDA
Marketing start
2025-11-18
Substance
DIAZEPAM
Active strength
5 mg/mL
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
DIAZEPAM5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui2120550

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
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-9769-02DIAZEPAM2 mL in 1 SYRINGEINJECTION21
0404-9769-02DIAZEPAM1 in 1 BAGINJECTION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSNdcf7bc20-6c57-491a-b9e3-f42bacff8b991
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCDdcf7bc20-6c57-491a-b9e3-f42bacff8b991
2120550diazepam 10 MG per 2 ML Prefilled SyringeSYdcf7bc20-6c57-491a-b9e3-f42bacff8b991

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0404-9769-02004049769021 SYRINGE in 1 BAG (0404-9769-02) / 2 mL in 1 SYRINGE1 syringe2025-11-18NoNoCurrent