FDA.reportPublic FDA data

Diazepam

Product NDC
71335-2247
11-digit product format
713352247
Labeler code
71335
Product ID
71335-2247_a6fbad04-9486-4993-9397-2c7d04b52d86
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA070325
Marketing category
ANDA
Marketing start
1985-09-04
Substance
DIAZEPAM
Active strength
2 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
DIAZEPAM2 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQ3JTX2Q7TU
Rxcui197590

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
71335-2247-1Diazepam30 in 1 BOTTLE, PLASTICTABLET30102
71335-2247-2Diazepam60 in 1 BOTTLE, PLASTICTABLET60102
71335-2247-3Diazepam20 in 1 BOTTLE, PLASTICTABLET20102
71335-2247-4Diazepam90 in 1 BOTTLE, PLASTICTABLET90102
71335-2247-5Diazepam120 in 1 BOTTLE, PLASTICTABLET120102
71335-2247-6Diazepam7 in 1 BOTTLE, PLASTICTABLET7102
71335-2247-7Diazepam2 in 1 BOTTLE, PLASTICTABLET2102
71335-2247-8Diazepam15 in 1 BOTTLE, PLASTICTABLET15102
71335-2247-9Diazepam45 in 1 BOTTLE, PLASTICTABLET45102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2247-1EA - Each71335-2247495fc2cb-de9b-4267-9798-84c4b806c8ef12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2247DIAZEPAM TABLET [BRYANT RANCH PREPACK]102Current NDC, 9 package rows20240824_632d7e96-d32c-45b8-86cf-f18ec2b35485.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197590diazePAM 2 MG Oral TabletPSN632d7e96-d32c-45b8-86cf-f18ec2b35485102
197590diazepam 2 MG Oral TabletSCD632d7e96-d32c-45b8-86cf-f18ec2b35485102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2247-17133522470130 TABLET in 1 BOTTLE, PLASTIC (71335-2247-1) 30 tablet2023-09-25NoNoHistorical
71335-2247-27133522470260 TABLET in 1 BOTTLE, PLASTIC (71335-2247-2) 60 tablet2023-09-25NoNoHistorical
71335-2247-37133522470320 TABLET in 1 BOTTLE, PLASTIC (71335-2247-3) 20 tablet2023-09-25NoNoHistorical
71335-2247-47133522470490 TABLET in 1 BOTTLE, PLASTIC (71335-2247-4) 90 tablet2023-09-25NoNoHistorical
71335-2247-571335224705120 TABLET in 1 BOTTLE, PLASTIC (71335-2247-5) 120 tablet2023-09-25NoNoHistorical
71335-2247-6713352247067 TABLET in 1 BOTTLE, PLASTIC (71335-2247-6) 7 tablet2023-09-25NoNoHistorical
71335-2247-7713352247072 TABLET in 1 BOTTLE, PLASTIC (71335-2247-7) 2 tablet2023-09-25NoNoHistorical
71335-2247-87133522470815 TABLET in 1 BOTTLE, PLASTIC (71335-2247-8) 15 tablet2023-09-25NoNoHistorical
71335-2247-97133522470945 TABLET in 1 BOTTLE, PLASTIC (71335-2247-9) 45 tablet2023-09-25NoNoHistorical