FDA.reportPublic FDA data

Diazepam

Product NDC
50090-1913
11-digit product format
500901913
Labeler code
50090
Product ID
50090-1913_8b32cbef-f70b-4b28-b267-9768b7a40197
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA071321
Marketing category
ANDA
Marketing start
1986-12-10
Substance
DIAZEPAM
Active strength
5 mg/1
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/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589, 197591

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50090-1913-02023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-12023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-22023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-32023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-42023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-52023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-62023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-72023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-82023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-92023-02-07C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-02023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-12023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-22023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-32023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-42023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-52023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-62023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-72023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-82023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only
50090-1913-92023-01-30C16284748780-1f386c649-d68f-0266-e053-dadaa90a7c1aDiazepam Tablets, USP, CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-1913-0Diazepam15 in 1 BOTTLETABLET1534
50090-1913-1Diazepam20 in 1 BOTTLETABLET2034
50090-1913-2Diazepam30 in 1 BOTTLETABLET3034
50090-1913-3Diazepam60 in 1 BOTTLETABLET6034
50090-1913-4Diazepam10 in 1 BOTTLETABLET1034
50090-1913-5Diazepam100 in 1 BOTTLETABLET10034
50090-1913-6Diazepam50 in 1 BOTTLETABLET5034
50090-1913-7Diazepam6 in 1 BOTTLETABLET634
50090-1913-8Diazepam3 in 1 BOTTLETABLET334
50090-1913-9Diazepam12 in 1 BOTTLETABLET1234

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-1913DIAZEPAM TABLET [A-S MEDICATION SOLUTIONS]32Current NDC, Legacy NDC, 10 package rows20250406_b47dc708-e83b-4224-bdb5-c9b7abd35cfb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNb47dc708-e83b-4224-bdb5-c9b7abd35cfb34
197591diazePAM 5 MG Oral TabletPSNb47dc708-e83b-4224-bdb5-c9b7abd35cfb34
197589diazepam 10 MG Oral TabletSCDb47dc708-e83b-4224-bdb5-c9b7abd35cfb34
197591diazepam 5 MG Oral TabletSCDb47dc708-e83b-4224-bdb5-c9b7abd35cfb34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-1913-05009019130015 TABLET in 1 BOTTLE (50090-1913-0) 15 tablet2015-07-020000-00-00NoNoCurrent
50090-1913-15009019130120 TABLET in 1 BOTTLE (50090-1913-1) 20 tablet2015-07-020000-00-00NoNoCurrent
50090-1913-25009019130230 TABLET in 1 BOTTLE (50090-1913-2) 30 tablet2015-07-020000-00-00NoNoCurrent
50090-1913-35009019130360 TABLET in 1 BOTTLE (50090-1913-3) 60 tablet2019-10-090000-00-00NoNoCurrent
50090-1913-45009019130410 TABLET in 1 BOTTLE (50090-1913-4) 10 tablet2015-07-020000-00-00NoNoCurrent
50090-1913-550090191305100 TABLET in 1 BOTTLE (50090-1913-5) 100 tablet2015-07-020000-00-00NoNoCurrent
50090-1913-65009019130650 TABLET in 1 BOTTLE (50090-1913-6) 50 tablet2019-10-090000-00-00NoNoCurrent
50090-1913-7500901913076 TABLET in 1 BOTTLE (50090-1913-7) 6 tablet2019-10-090000-00-00NoNoCurrent
50090-1913-8500901913083 TABLET in 1 BOTTLE (50090-1913-8) 3 tablet2019-10-090000-00-00NoNoCurrent
50090-1913-95009019130912 TABLET in 1 BOTTLE (50090-1913-9) 12 tablet2019-10-090000-00-00NoNoCurrent