FDA.reportPublic FDA data

Diazepam

Product NDC
43598-106
11-digit product format
435980106
Labeler code
43598
Product ID
43598-106_429d0ffe-9774-b285-8534-bb76611da385
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Dr. Reddy's Laboratories Inc
Application
ANDA218422
Marketing category
ANDA
Marketing start
2024-08-07
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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43598-106-10Diazepam10 in 1 CARTONINJECTION, SOLUTION104
43598-106-11Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION24
43598-106-11Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION21
43598-106-58Diazepam10 in 1 CARTONINJECTION, SOLUTION101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43598-106-10ML - Milliliter43598-10647807f22-4bae-4908-b8da-3baabd5eb12612024-08-12
43598-106-11ML - Milliliter43598-10611de9a4f-b71c-41d4-b275-7f6ac4d583fd12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43598-106DIAZEPAM INJECTION, SOLUTION [DR. REDDY'S LABORATORIES INC]4Current NDC, 2 package rows20240810_2a633cef-6dfc-4186-b595-174db2d8330e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSN2a633cef-6dfc-4186-b595-174db2d8330e4
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCD2a633cef-6dfc-4186-b595-174db2d8330e4
2120550diazepam 10 MG per 2 ML Prefilled SyringeSY2a633cef-6dfc-4186-b595-174db2d8330e4
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSN9a860a4e-d670-d050-499d-eb1fd6b161761
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCD9a860a4e-d670-d050-499d-eb1fd6b161761
2120550diazepam 10 MG per 2 ML Prefilled SyringeSY9a860a4e-d670-d050-499d-eb1fd6b161761

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43598-106-104359801061010 SYRINGE, GLASS in 1 CARTON (43598-106-10) / 2 mL in 1 SYRINGE, GLASS (43598-106-11) 2024-08-07NoNoCurrent
43598-106-11435980106112 mL in 1 SYRINGE, GLASS2 mlHistorical
43598-106-584359801065810 SYRINGE, GLASS in 1 CARTON (43598-106-58) / 2 mL in 1 SYRINGE, GLASS (43598-106-11) 2026-05-11NoNoCurrent