Diazepam

Product NDC
17856-3188
11-digit product format
178563188
Labeler code
17856
Product ID
17856-3188_8fdd853b-41bf-4474-87db-e86cb2bfd21a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA070928
Marketing category
ANDA
Marketing start
1987-04-03
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/5mL
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
17856-3188-12026-01-29C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-32026-01-29C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-42026-01-29C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-12024-05-20C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-32024-05-20C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-42024-05-20C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-12022-01-28C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-32022-01-28C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-42022-01-28C16284748780-1d6a99b39-fea7-a426-e053-dadaa90af4c2Diazepam Oral Solution, CIV, 5 mg per 5 mL and Diazepam Intensol ™ Oral Solution (Concentrate), CIV, 25 mg per 5 mL (5 mg/mL)
17856-3188-22020-01-31C16284748780-19d75b9cf-d985-f424-e053-dadaa90a57ceDIAZEPAM ORAL SOLUTION, CIV

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-3188-1Diazepam0.8 mL in 1 SYRINGESOLUTION0.84
17856-3188-1Diazepam60 in 1 BOX, UNIT-DOSESOLUTION604
17856-3188-3Diazepam120 in 1 BOX, UNIT-DOSESOLUTION1204
17856-3188-3Diazepam0.8 mL in 1 SYRINGESOLUTION0.84
17856-3188-4Diazepam72 in 1 BOX, UNIT-DOSESOLUTION724
17856-3188-4Diazepam5.0 mL in 1 CUP, UNIT-DOSESOLUTION5.04
17856-3188-2Diazepam2 mL in 1 CUPSOLUTION21

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-3188DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORP.]4Legacy NDC, 6 package rows20240522_e435e56f-e6eb-4fe9-9a8f-e11527778fc1.zip
17856-3188DIAZEPAM SOLUTION [ATLANTIC BIOLOGICALS CORPS]1Legacy NDC, 1 package rows20110916_5051e98b-3817-61aa-dba8-bd8be2f0c086.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309843diazePAM 5 MG in 5 mL Oral SolutionPSNe435e56f-e6eb-4fe9-9a8f-e11527778fc14
309843diazepam 1 MG/ML Oral SolutionSCDe435e56f-e6eb-4fe9-9a8f-e11527778fc14
309843diazepam 5 MG per 5 ML Oral SolutionSYe435e56f-e6eb-4fe9-9a8f-e11527778fc14
309843diazePAM 5 MG in 5 mL Oral SolutionPSN5051e98b-3817-61aa-dba8-bd8be2f0c0861
309843diazepam 1 MG/ML Oral SolutionSCD5051e98b-3817-61aa-dba8-bd8be2f0c0861
309843diazepam 5 MG per 5 ML Oral SolutionSY5051e98b-3817-61aa-dba8-bd8be2f0c0861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-3188-11785631880160 SYRINGE in 1 BOX, UNIT-DOSE (17856-3188-1) > .8 mL in 1 SYRINGE60 syringe2020-03-060000-00-00NoNoCurrent
17856-3188-2178563188022 mL in 1 CUP2 mlHistorical
17856-3188-317856318803120 SYRINGE in 1 BOX, UNIT-DOSE (17856-3188-3) > .8 mL in 1 SYRINGE120 syringe2020-07-060000-00-00NoNoCurrent
17856-3188-41785631880472 CUP, UNIT-DOSE in 1 BOX, UNIT-DOSE (17856-3188-4) > 5 mL in 1 CUP, UNIT-DOSE2020-11-040000-00-00NoNoCurrent