Diazepam

Product NDC
68682-650
11-digit product format
686820650
Labeler code
68682
Product ID
68682-650_0e23d654-d8b9-af1c-e063-6294a90a6f14
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
GEL
Route
RECTAL
Labeler
Oceanside Pharmaceuticals
Application
NDA020648
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
1997-07-29
Substance
DIAZEPAM
Active strength
2.5 mg/.5mL
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
DIAZEPAM2.5 mg/.5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui801957, 801961, 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
68682-650-20Diazepam0.5 mL in 1 SYRINGE, PLASTICGEL0.56
68682-650-20Diazepam2 in 1 PACKAGEGEL26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68682-650-20EA - Each68682-65062b09185-f2a8-4ae6-ae13-842d0d0c57d112017-09-11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68682-650DIAZEPAM GEL DIAZEPAM GEL [OCEANSIDE PHARMACEUTICALS]6Current NDC, Legacy NDC, 2 package rows20240105_b1b2848b-b265-4f6f-9141-bf106dec0726.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
801961diazePAM 10 MG in 2 ML Rectal GelPSNb1b2848b-b265-4f6f-9141-bf106dec07266
801957diazePAM 2.5 MG in 0.5 ML Rectal GelPSNb1b2848b-b265-4f6f-9141-bf106dec07266
801966diazePAM 20 MG in 4 ML Rectal GelPSNb1b2848b-b265-4f6f-9141-bf106dec07266
8019570.5 ML diazepam 5 MG/ML Rectal GelSCDb1b2848b-b265-4f6f-9141-bf106dec07266
8019612 ML diazepam 5 MG/ML Rectal GelSCDb1b2848b-b265-4f6f-9141-bf106dec07266
8019664 ML diazepam 5 MG/ML Rectal GelSCDb1b2848b-b265-4f6f-9141-bf106dec07266
801961diazepam 10 MG per 2 ML Rectal GelSYb1b2848b-b265-4f6f-9141-bf106dec07266
801957diazepam 2.5 MG per 0.5 ML Rectal GelSYb1b2848b-b265-4f6f-9141-bf106dec07266
801966diazepam 20 mg per 4 ML Rectal GelSYb1b2848b-b265-4f6f-9141-bf106dec07266

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68682-650-20686820650202 SYRINGE, PLASTIC in 1 PACKAGE (68682-650-20) / .5 mL in 1 SYRINGE, PLASTIC1997-07-290000-00-00NoNoCurrent