FDA.reportPublic FDA data

Diazepam

Product NDC
71335-2197
11-digit product format
713352197
Labeler code
71335
Product ID
71335-2197_a6be1a31-f916-483a-893d-7415297a45f7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071135
Marketing category
ANDA
Marketing start
2019-10-31
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2197-0Diazepam120 in 1 BOTTLE, PLASTICTABLET120104
71335-2197-1Diazepam12 in 1 BOTTLE, PLASTICTABLET12104
71335-2197-2Diazepam15 in 1 BOTTLE, PLASTICTABLET15104
71335-2197-3Diazepam20 in 1 BOTTLE, PLASTICTABLET20104
71335-2197-4Diazepam30 in 1 BOTTLE, PLASTICTABLET30104
71335-2197-5Diazepam60 in 1 BOTTLE, PLASTICTABLET60104
71335-2197-6Diazepam90 in 1 BOTTLE, PLASTICTABLET90104
71335-2197-7Diazepam10 in 1 BOTTLE, PLASTICTABLET10104
71335-2197-8Diazepam2 in 1 BOTTLE, PLASTICTABLET2104
71335-2197-9Diazepam1 in 1 BOTTLE, PLASTICTABLET1104

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2197-8EA - Each71335-21979967556f-7ace-4fe6-b95e-022eab34ea7e12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2197DIAZEPAM TABLET [BRYANT RANCH PREPACK]104Legacy NDC, 10 package rows20240809_1a71582e-ffca-481f-bf90-4f26ae2c8760.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197591diazePAM 5 MG Oral TabletPSN1a71582e-ffca-481f-bf90-4f26ae2c8760104
197591diazepam 5 MG Oral TabletSCD1a71582e-ffca-481f-bf90-4f26ae2c8760104

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2197-071335219700120 TABLET in 1 BOTTLE, PLASTIC (71335-2197-0) 120 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-17133521970112 TABLET in 1 BOTTLE, PLASTIC (71335-2197-1) 12 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-27133521970215 TABLET in 1 BOTTLE, PLASTIC (71335-2197-2) 15 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-37133521970320 TABLET in 1 BOTTLE, PLASTIC (71335-2197-3) 20 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-47133521970430 TABLET in 1 BOTTLE, PLASTIC (71335-2197-4) 30 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-57133521970560 TABLET in 1 BOTTLE, PLASTIC (71335-2197-5) 60 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-67133521970690 TABLET in 1 BOTTLE, PLASTIC (71335-2197-6) 90 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-77133521970710 TABLET in 1 BOTTLE, PLASTIC (71335-2197-7) 10 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-8713352197082 TABLET in 1 BOTTLE, PLASTIC (71335-2197-8) 2 tablet2022-12-050000-00-00NoNoCurrent
71335-2197-9713352197091 TABLET in 1 BOTTLE, PLASTIC (71335-2197-9) 1 tablet2022-12-050000-00-00NoNoCurrent