FDA.reportPublic FDA data

Diazepam

Product NDC
70518-0162
11-digit product format
705180162
Labeler code
70518
Product ID
70518-0162_4b1e1881-5865-403c-e063-6294a90af3d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071322
Marketing category
ANDA
Marketing start
2017-01-23
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diazepam
Listing expiration
2027-12-31

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
70518-0162-0Diazepam30 in 1 BLISTER PACKTABLET3024
70518-0162-1Diazepam100 in 1 BOXTABLET10024
70518-0162-2Diazepam1 in 1 POUCHTABLET124
70518-0162-3Diazepam2 in 1 BOTTLE, PLASTICTABLET224
70518-0162-4Diazepam30 in 1 BOTTLE, PLASTICTABLET3024

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-0162DIAZEPAM TABLET [REMEDYREPACK INC.]19Current NDC, Legacy NDC, 5 package rows20250529_5ebef149-1858-4199-aaed-7b9341fae63d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN5ebef149-1858-4199-aaed-7b9341fae63d24
197589diazepam 10 MG Oral TabletSCD5ebef149-1858-4199-aaed-7b9341fae63d24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-0162-07051801620030 TABLET in 1 BLISTER PACK (70518-0162-0) 30 tablet2017-01-230000-00-00NoNoCurrent
70518-0162-170518016201100 POUCH in 1 BOX (70518-0162-1) > 1 TABLET in 1 POUCH (70518-0162-2) 100 pouch2020-01-160000-00-00NoNoCurrent
70518-0162-2705180162021 in 1 POUCHHistorical
70518-0162-3705180162032 TABLET in 1 BOTTLE, PLASTIC (70518-0162-3) 2 tablet2021-05-280000-00-00NoNoCurrent
70518-0162-47051801620430 in 1 BOTTLE, PLASTICHistorical