FDA.reportPublic FDA data

Diazepam

Product NDC
76045-204
11-digit product format
760450204
Labeler code
76045
Product ID
76045-204_c6b235b0-6b36-4e9b-a214-2b924f0d4126
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Fresenius Kabi USA, LLC
Application
ANDA214745
Marketing category
ANDA
Marketing start
2022-11-10
Substance
DIAZEPAM
Active strength
10 mg/2mL
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/2mL

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
76045-204-00Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION22
76045-204-20Diazepam24 in 1 CARTONINJECTION, SOLUTION242

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76045-204-00ML - Milliliter76045-204509ab857-369f-4595-822c-ba892359c30512023-05-05
76045-204-20ML - Milliliter76045-204c126f674-1175-483a-944b-d5d6f320ec0112023-05-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76045-204DIAZEPAM INJECTION, SOLUTION [FRESENIUS KABI USA, LLC]1Current NDC, Legacy NDC, 2 package rows20230107_ae52866a-0b9a-4baf-af1b-f9d5e00c0e56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSNae52866a-0b9a-4baf-af1b-f9d5e00c0e562
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCDae52866a-0b9a-4baf-af1b-f9d5e00c0e562
2120550diazepam 10 MG per 2 ML Prefilled SyringeSYae52866a-0b9a-4baf-af1b-f9d5e00c0e562

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76045-204-00760450204002 mL in 1 SYRINGE, GLASS2 mlHistorical
76045-204-207604502042024 SYRINGE, GLASS in 1 CARTON (76045-204-20) / 2 mL in 1 SYRINGE, GLASS (76045-204-00) 2022-11-100000-00-00NoNoCurrent