FDA.reportPublic FDA data

Diazepam

Product NDC
71335-1584
11-digit product format
713351584
Labeler code
71335
Product ID
71335-1584_dc33c03b-c55f-4b37-9b2b-85c949d2a1c3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
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
Rxcui197591

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
71335-1584-02024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-12024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-22024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-32024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-42024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-52024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-62024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-72024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-82024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-92024-05-21C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-02024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-12024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-22024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-32024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-42024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-52024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-62024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-72024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-82024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only
71335-1584-92024-01-30C16284748780-11030e365-6dd0-111a-e063-dadaa90a10e2Diazepam Tablets, USP, CIV Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1584-0Diazepam120 in 1 BOTTLETABLET120101
71335-1584-1Diazepam12 in 1 BOTTLETABLET12101
71335-1584-2Diazepam15 in 1 BOTTLETABLET15101
71335-1584-3Diazepam20 in 1 BOTTLETABLET20101
71335-1584-4Diazepam30 in 1 BOTTLETABLET30101
71335-1584-5Diazepam60 in 1 BOTTLETABLET60101
71335-1584-6Diazepam90 in 1 BOTTLETABLET90101
71335-1584-7Diazepam10 in 1 BOTTLETABLET10101
71335-1584-8Diazepam2 in 1 BOTTLETABLET2101
71335-1584-9Diazepam1 in 1 BOTTLETABLET1101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1584DIAZEPAM TABLET [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 10 package rows20240522_6abedac6-5133-47b2-a0e3-e239e0a2254b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN6abedac6-5133-47b2-a0e3-e239e0a2254b101
197591diazepam 5 MG Oral TabletSCD6abedac6-5133-47b2-a0e3-e239e0a2254b101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1584-071335158400120 TABLET in 1 BOTTLE (71335-1584-0) 120 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-17133515840112 TABLET in 1 BOTTLE (71335-1584-1) 12 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-27133515840215 TABLET in 1 BOTTLE (71335-1584-2) 15 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-37133515840320 TABLET in 1 BOTTLE (71335-1584-3) 20 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-47133515840430 TABLET in 1 BOTTLE (71335-1584-4) 30 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-57133515840560 TABLET in 1 BOTTLE (71335-1584-5) 60 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-67133515840690 TABLET in 1 BOTTLE (71335-1584-6) 90 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-77133515840710 TABLET in 1 BOTTLE (71335-1584-7) 10 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-8713351584082 TABLET in 1 BOTTLE (71335-1584-8) 2 tablet2022-02-100000-00-00NoNoCurrent
71335-1584-9713351584091 TABLET in 1 BOTTLE (71335-1584-9) 1 tablet2022-02-100000-00-00NoNoCurrent