Diazepam

Product NDC
68094-750
11-digit product format
680940750
Labeler code
68094
Product ID
68094-750_59e9e7be-3727-4bb0-ac6d-100d4dbb0603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
SOLUTION
Route
ORAL
Labeler
Precision Dose Inc.
Application
ANDA070928
Marketing category
ANDA
Marketing start
2012-02-22
Substance
DIAZEPAM
Active strength
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
DIAZEPAM5 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui309843

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
2c487d7e-cbfc-4699-9c83-5c1c7521cde9Product name120200610
02ac201d-7ee6-00c9-f963-81bb5a506b68Product name320160816

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68094-750-59Diazepam5 mL in 1 CUP, UNIT-DOSESOLUTION59
68094-750-62Diazepam3 in 1 CASESOLUTION39
68094-750-62Diazepam10 in 1 TRAYSOLUTION109

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68094-750-59ML - Milliliter68094-750dee346db-7c82-47b0-bdef-81d7148c737012012-07-24
68094-750-62ML - Milliliter68094-75086c6d163-f3d1-44bb-a086-d4071f31c58512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DiazepamACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
DiazepamACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOADIAZEPAM SOLUTION [PRECISION DOSE INC.]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1ADIAZEPAM SOLUTION [PRECISION DOSE INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3DIAZEPAM SOLUTION [PRECISION DOSE INC.]1
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
SORBITOLINACTIVE INGREDIENT506T60A25RDIAZEPAM SOLUTION [PRECISION DOSE INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIAZEPAM SOLUTION [PRECISION DOSE INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68094-750DIAZEPAM SOLUTION [PRECISION DOSE INC.]8Current NDC, Legacy NDC, 3 package rows20240404_78d5a77d-5ca7-4f16-b4d0-fce86456593c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309843diazePAM 5 MG in 5 mL Oral SolutionPSN78d5a77d-5ca7-4f16-b4d0-fce86456593c9
309843diazepam 1 MG/ML Oral SolutionSCD78d5a77d-5ca7-4f16-b4d0-fce86456593c9
309843diazepam 5 MG per 5 ML Oral SolutionSY78d5a77d-5ca7-4f16-b4d0-fce86456593c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68094-750-59680940750595 mL in 1 CUP, UNIT-DOSE5 mlHistorical
68094-750-62680940750623 TRAY in 1 CASE (68094-750-62) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (68094-750-59) 3 tray2012-02-220000-00-00NoNoCurrent