FDA.reportPublic FDA data

Diazepam

Product NDC
71610-424
11-digit product format
716100424
Labeler code
71610
Product ID
71610-424_674e8116-e236-44a6-92f3-2f33fde550fd
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071322
Marketing category
ANDA
Marketing start
1986-12-10
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
71610-424-15Diazepam15 in 1 BOTTLETABLET156
71610-424-30Diazepam30 in 1 BOTTLETABLET306
71610-424-45Diazepam45 in 1 BOTTLETABLET456
71610-424-53Diazepam60 in 1 BOTTLETABLET606
71610-424-60Diazepam90 in 1 BOTTLETABLET906
71610-424-70Diazepam120 in 1 BOTTLETABLET1206

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-424-15EA - Each71610-424c115dad6-db99-4992-87b9-7f717a2bdd0712022-11-07
71610-424-30EA - Each71610-424af12555e-6620-4ee4-adaf-eb43c039902612020-07-13
71610-424-45EA - Each71610-42416010a1b-cc06-4462-8725-7471fd2480c812022-10-06
71610-424-53EA - Each71610-424a93b5ece-66de-484a-9b14-d7b7f9cd59aa12020-07-13
71610-424-60EA - Each71610-42430138bf6-6188-4157-ba9c-887f3afcd3ad12020-07-13
71610-424-70EA - Each71610-424cbee9e27-2285-42cc-87be-0a82df80ed8012020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-424DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]6Current NDC, Legacy NDC, 6 package rows20220904_9cf031ae-d59b-430d-9b15-415ae2e49c98.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN9cf031ae-d59b-430d-9b15-415ae2e49c986
197589diazepam 10 MG Oral TabletSCD9cf031ae-d59b-430d-9b15-415ae2e49c986

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-424-157161004241515 TABLET in 1 BOTTLE (71610-424-15) 15 tablet2022-09-010000-00-00NoNoCurrent
71610-424-307161004243030 TABLET in 1 BOTTLE (71610-424-30) 30 tablet2020-05-070000-00-00NoNoCurrent
71610-424-457161004244545 TABLET in 1 BOTTLE (71610-424-45) 45 tablet2022-08-040000-00-00NoNoCurrent
71610-424-537161004245360 TABLET in 1 BOTTLE (71610-424-53) 60 tablet2020-05-070000-00-00NoNoCurrent
71610-424-607161004246090 TABLET in 1 BOTTLE (71610-424-60) 90 tablet2020-05-070000-00-00NoNoCurrent
71610-424-7071610042470120 TABLET in 1 BOTTLE (71610-424-70) 120 tablet2020-05-070000-00-00NoNoCurrent