Diazepam

Product NDC
0121-0905
11-digit product format
001210905
Labeler code
0121
Product ID
0121-0905_cc0d49f5-c681-9d48-e053-2a95a90a597b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
SOLUTION
Route
ORAL
Labeler
Pharmaceutical Associates, Inc.
Application
ANDA070928
Marketing category
ANDA
Marketing start
1987-04-03
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
0121-0905-05Diazepam5 mL in 1 CUP, UNIT-DOSESOLUTION52
0121-0905-94Diazepam3 in 1 CASESOLUTION32
0121-0905-94Diazepam10 in 1 TRAYSOLUTION102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0121-0905-05ML - Milliliter0121-0905e32cd6ee-4bfa-461a-b74f-848cbbcc5b1312021-04-08
0121-0905-94ML - Milliliter0121-0905ca58f606-bdd7-4027-a8d8-c3c8e053e76812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0121-0905DIAZEPAM SOLUTION [PHARMACEUTICAL ASSOCIATES, INC.]2Current NDC, Legacy NDC, 3 package rows20210917_b24f1eb7-3dab-4183-b81f-f86ac62aedd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309843diazePAM 5 MG in 5 mL Oral SolutionPSNb24f1eb7-3dab-4183-b81f-f86ac62aedd82
309843diazepam 1 MG/ML Oral SolutionSCDb24f1eb7-3dab-4183-b81f-f86ac62aedd82
309843diazepam 5 MG per 5 ML Oral SolutionSYb24f1eb7-3dab-4183-b81f-f86ac62aedd82

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0121-0905-05001210905055 mL in 1 CUP, UNIT-DOSE5 mlHistorical
0121-0905-94001210905943 TRAY in 1 CASE (0121-0905-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0905-05) 3 tray2021-02-260000-00-00NoNoCurrent