FDA.reportPublic FDA data

Diazepam

Product NDC
72572-140
11-digit product format
725720140
Labeler code
72572
Product ID
72572-140_7c8644aa-0bb2-4573-b238-681b82933f0b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Civica, Inc.
Application
ANDA210363
Marketing category
ANDA
Marketing start
2019-12-01
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
72572-140-01Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION27
72572-140-02Diazepam10 in 1 CARTONINJECTION, SOLUTION107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72572-140-01ML - Milliliter72572-140107ca922-3ade-4f2a-9eb6-f579bb8e378512020-01-03
72572-140-02ML - Milliliter72572-140999cc25c-cc4e-4ed9-a34f-9cc34b0181fb12020-01-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72572-140DIAZEPAM INJECTION, SOLUTION [CIVICA, INC.]7Current NDC, Legacy NDC, 2 package rows20250410_83646a0f-eb43-4871-b95e-683c2533d2be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSN83646a0f-eb43-4871-b95e-683c2533d2be7
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCD83646a0f-eb43-4871-b95e-683c2533d2be7
2120550diazepam 10 MG per 2 ML Prefilled SyringeSY83646a0f-eb43-4871-b95e-683c2533d2be7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72572-140-01725720140012 mL in 1 SYRINGE, GLASS2 mlHistorical
72572-140-027257201400210 SYRINGE, GLASS in 1 CARTON (72572-140-02) / 2 mL in 1 SYRINGE, GLASS (72572-140-01) 2019-12-010000-00-00NoNoCurrent