FDA.reportPublic FDA data

Diazepam

Product NDC
63629-2948
11-digit product format
636292948
Labeler code
63629
Product ID
63629-2948_794d7766-49c6-4872-b798-89bd6c634fbb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071307
Marketing category
ANDA
Marketing start
1986-12-10
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
63629-2948-1Diazepam30 in 1 BOTTLETABLET301014
63629-2948-2Diazepam60 in 1 BOTTLETABLET601014
63629-2948-3Diazepam20 in 1 BOTTLETABLET201014
63629-2948-4Diazepam90 in 1 BOTTLETABLET901014
63629-2948-5Diazepam120 in 1 BOTTLETABLET1201014
63629-2948-6Diazepam7 in 1 BOTTLETABLET71014
63629-2948-7Diazepam2 in 1 BOTTLETABLET21014
63629-2948-8Diazepam15 in 1 BOTTLETABLET151014
63629-2948-9Diazepam45 in 1 BOTTLETABLET451014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-2948-1EA - Each63629-2948b0313aeb-0429-438c-942c-b7e080540ea212013-03-03
63629-2948-2EA - Each63629-2948675061d4-4a46-4fa7-bb48-144a361e0bca12013-03-03
63629-2948-3EA - Each63629-2948ec3f9bee-7ca5-4ec5-83de-491358616feb12013-03-03
63629-2948-4EA - Each63629-29485d3a5c78-aa74-4f18-bc1e-43265cfef63812013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [BRYANT RANCH PREPACK]1001
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [BRYANT RANCH PREPACK]1001

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-2948DIAZEPAM TABLET [BRYANT RANCH PREPACK]1014Current NDC, Legacy NDC, 9 package rows20240511_04cc10ad-7d5c-434e-9b29-85b14071492b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197590diazePAM 2 MG Oral TabletPSN04cc10ad-7d5c-434e-9b29-85b14071492b1014
197590diazepam 2 MG Oral TabletSCD04cc10ad-7d5c-434e-9b29-85b14071492b1014

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-2948-16362929480130 TABLET in 1 BOTTLE (63629-2948-1) 30 tablet2006-07-280000-00-00NoNoCurrent
63629-2948-26362929480260 TABLET in 1 BOTTLE (63629-2948-2) 60 tablet2006-08-150000-00-00NoNoCurrent
63629-2948-36362929480320 TABLET in 1 BOTTLE (63629-2948-3) 20 tablet2014-03-210000-00-00NoNoCurrent
63629-2948-46362929480490 TABLET in 1 BOTTLE (63629-2948-4) 90 tablet2012-07-090000-00-00NoNoCurrent
63629-2948-563629294805120 TABLET in 1 BOTTLE (63629-2948-5) 120 tablet2021-12-220000-00-00NoNoCurrent
63629-2948-6636292948067 TABLET in 1 BOTTLE (63629-2948-6) 7 tablet2021-12-220000-00-00NoNoCurrent
63629-2948-7636292948072 TABLET in 1 BOTTLE (63629-2948-7) 2 tablet2021-12-220000-00-00NoNoCurrent
63629-2948-86362929480815 TABLET in 1 BOTTLE (63629-2948-8) 15 tablet2017-11-010000-00-00NoNoCurrent
63629-2948-96362929480945 TABLET in 1 BOTTLE (63629-2948-9) 45 tablet2017-11-01NoNoHistorical