FDA.reportPublic FDA data

Diazepam

Product NDC
43386-280
11-digit product format
433860280
Labeler code
43386
Product ID
43386-280_91b10d2a-111a-4f2b-8b9a-d9c5d4a783f5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
GEL
Route
RECTAL
Labeler
Lupin Pharmaceuticals,Inc.
Application
ANDA091076
Marketing category
ANDA
Marketing start
2023-10-30
Substance
DIAZEPAM
Active strength
10 mg/2g
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/2g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui801961, 801966

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
43386-280-01Diazepam2 in 1 PACKAGEGEL28
43386-280-02Diazepam1 in 1 CARTONGEL18
43386-280-03Diazepam2 g in 1 SYRINGEGEL28

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43386-280DIAZEPAM GEL [LUPIN PHARMACEUTICALS,INC.]7Current NDC, 3 package rows20231216_d99b68aa-b3dc-49c8-8894-3da255cd26b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801961diazePAM 10 MG in 2 ML Rectal GelPSNd99b68aa-b3dc-49c8-8894-3da255cd26b08
801966diazePAM 20 MG in 4 ML Rectal GelPSNd99b68aa-b3dc-49c8-8894-3da255cd26b08
8019612 ML diazepam 5 MG/ML Rectal GelSCDd99b68aa-b3dc-49c8-8894-3da255cd26b08
8019664 ML diazepam 5 MG/ML Rectal GelSCDd99b68aa-b3dc-49c8-8894-3da255cd26b08
801961diazepam 10 MG per 2 ML Rectal GelSYd99b68aa-b3dc-49c8-8894-3da255cd26b08
801966diazepam 20 mg per 4 ML Rectal GelSYd99b68aa-b3dc-49c8-8894-3da255cd26b08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
43386-280-01433860280012 in 1 PACKAGEHistorical
43386-280-02433860280021 PACKAGE in 1 CARTON (43386-280-02) / 2 SYRINGE in 1 PACKAGE (43386-280-01) / 2 g in 1 SYRINGE (43386-280-03) 1 package2023-10-30YesNoCurrent
43386-280-03433860280032 g in 1 SYRINGE2 gHistorical