FDA.reportPublic FDA data

Diazepam

Product NDC
69339-136
11-digit product format
693390136
Labeler code
69339
Product ID
69339-136_169f5115-24f1-4e7e-8981-5df941ce087d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
INJECTION, SOLUTION
Route
INTRAMUSCULAR; INTRAVENOUS
Labeler
Natco Pharma USA LLC
Application
ANDA210363
Marketing category
ANDA
Marketing start
2019-03-22
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
69339-136-02Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION27
69339-136-03Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION27
69339-136-32Diazepam10 in 1 CARTONINJECTION, SOLUTION107
69339-136-34Diazepam10 in 1 CARTONINJECTION, SOLUTION107
69339-136-93Diazepam2 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION22
69339-136-97Diazepam10 in 1 CARTONINJECTION, SOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69339-136-02ML - Milliliter69339-136e6795636-7bbc-4d91-a0cf-3de39f5efb6012019-04-11
69339-136-03ML - Milliliter69339-1368e052115-472b-41ef-9e2b-bf1ae12584ee12021-05-05
69339-136-32ML - Milliliter69339-136da5f8fe7-f672-46b2-8d93-fad639828e7912019-04-11
69339-136-34ML - Milliliter69339-13604609edd-5df2-44ca-9e3f-ddd5c2063d7d12021-05-05
69339-136-93ML - Milliliter69339-136d710166b-35ca-4143-af18-53e703948ec012025-06-13
69339-136-97ML - Milliliter69339-1366a391eb6-dea3-4963-b82a-e8a767aa2e8512025-06-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69339-136DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC]6Current NDC, Legacy NDC, 4 package rows20250302_6b8dc373-fa01-42c9-89af-4e00bf00180a.zip
69339-136DIAZEPAM INJECTION, SOLUTION [NATCO PHARMA USA LLC]2Current NDC, Legacy NDC, 2 package rows20250429_a14f5930-a3ac-4996-9778-df5baa3d0bab.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
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSN6b8dc373-fa01-42c9-89af-4e00bf00180a7
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCD6b8dc373-fa01-42c9-89af-4e00bf00180a7
2120550diazepam 10 MG per 2 ML Prefilled SyringeSY6b8dc373-fa01-42c9-89af-4e00bf00180a7
2120550diazePAM 10 MG in 2 ML Prefilled SyringePSNa14f5930-a3ac-4996-9778-df5baa3d0bab2
21205502 ML diazepam 5 MG/ML Prefilled SyringeSCDa14f5930-a3ac-4996-9778-df5baa3d0bab2
2120550diazepam 10 MG per 2 ML Prefilled SyringeSYa14f5930-a3ac-4996-9778-df5baa3d0bab2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69339-136-02693390136022 mL in 1 SYRINGE, GLASS2 mlHistorical
69339-136-03693390136032 mL in 1 SYRINGE, GLASS2 mlHistorical
69339-136-326933901363210 SYRINGE, GLASS in 1 CARTON (69339-136-32) > 2 mL in 1 SYRINGE, GLASS (69339-136-02) 2019-03-222022-09-30NoNoCurrent
69339-136-346933901363410 SYRINGE, GLASS in 1 CARTON (69339-136-34) / 2 mL in 1 SYRINGE, GLASS (69339-136-03) 2021-04-010000-00-00NoNoCurrent
69339-136-93693390136932 mL in 1 SYRINGE, GLASS2 mlHistorical
69339-136-976933901369710 SYRINGE, GLASS in 1 CARTON (69339-136-97) / 2 mL in 1 SYRINGE, GLASS (69339-136-93) 2025-05-01NoNoHistorical