FDA.reportPublic FDA data

Diazepam

Product NDC
70518-2358
11-digit product format
705182358
Labeler code
70518
Product ID
70518-2358_4dde300d-23e7-8e06-e063-6294a90a417b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
REMEDYREPACK INC.
Application
ANDA210363
Marketing category
ANDA
Marketing start
2019-10-10
Substance
DIAZEPAM
Active strength
10 mg/2mL
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2027-12-31

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
70518-2358-0Diazepam10 in 1 CARTONINJECTION, SOLUTION1017
70518-2358-0Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION217
70518-2358-1Diazepam10 in 1 CARTONINJECTION, SOLUTION1017
70518-2358-2Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION217

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70518-2358-1ML - Milliliter70518-2358bc6d4069-2871-47f8-819c-dfc3260195ea12026-01-08
70518-2358-2ML - Milliliter70518-23584198185b-2abb-43bc-ab72-c0462aebf6b012026-01-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2358DIAZEPAM INJECTION, SOLUTION [REMEDYREPACK INC.]11Current NDC, Legacy NDC, 4 package rows20250426_c57af2a2-aa9a-4dac-a200-e0d845005d05.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSNc57af2a2-aa9a-4dac-a200-e0d845005d0517
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCDc57af2a2-aa9a-4dac-a200-e0d845005d0517
2120550diazepam 10 MG per 2 ML Prefilled SyringeSYc57af2a2-aa9a-4dac-a200-e0d845005d0517

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2358-07051823580010 SYRINGE, GLASS in 1 CARTON (70518-2358-0) > 2 mL in 1 SYRINGE, GLASS2019-10-100000-00-00NoNoCurrent
70518-2358-17051823580110 SYRINGE, GLASS in 1 CARTON (70518-2358-1) / 2 mL in 1 SYRINGE, GLASS (70518-2358-2) 2021-06-180000-00-00NoNoCurrent
70518-2358-2705182358022 mL in 1 SYRINGE, GLASS2 mlHistorical