FDA.reportPublic FDA data

DIAZEPAM

Product NDC
80425-0511
11-digit product format
804250511
Labeler code
80425
Product ID
80425-0511_32c39455-1398-b87a-e063-6394a90a9597
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
DIAZEPAM
Dosage form
TABLET
Route
ORAL
Labeler
Advanced Rx of Tennessee, LLC
Application
ANDA217843
Marketing category
ANDA
Marketing start
2025-04-14
Substance
DIAZEPAM
Active strength
10 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
DIAZEPAM10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197589

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
80425-0511-1DIAZEPAM30 in 1 BOTTLETABLET301
80425-0511-2DIAZEPAM60 in 1 BOTTLETABLET601
80425-0511-3DIAZEPAM90 in 1 BOTTLETABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0511-1EA - Each80425-0511d590c1ad-9bea-45bc-bbfb-1466c8a2390f12025-05-14
80425-0511-2EA - Each80425-0511f7d5cb53-d710-4c70-a53a-f753875cf39b12025-05-14
80425-0511-3EA - Each80425-0511227b7352-fb5f-494e-b31b-c5e1a6eca61712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0511DIAZEPAM TABLET [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20250419_32c3af91-a57a-1278-e063-6294a90ae5ec.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN32c3af91-a57a-1278-e063-6294a90ae5ec1
197589diazepam 10 MG Oral TabletSCD32c3af91-a57a-1278-e063-6294a90ae5ec1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0511-18042505110130 TABLET in 1 BOTTLE (80425-0511-1) 30 tablet2025-04-14NoNoHistorical
80425-0511-28042505110260 TABLET in 1 BOTTLE (80425-0511-2) 60 tablet2025-04-14NoNoHistorical
80425-0511-38042505110390 TABLET in 1 BOTTLE (80425-0511-3) 90 tablet2025-04-14NoNoHistorical