Diazepam

Product NDC
68788-9207
11-digit product format
687889207
Labeler code
68788
Product ID
68788-9207_b917cdf5-0881-4503-ba5c-a9a4fcae95a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA071322
Marketing category
ANDA
Marketing start
2011-11-09
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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
68788-9207-2Diazepam20 in 1 BOTTLETABLET202
68788-9207-3Diazepam30 in 1 BOTTLETABLET302
68788-9207-6Diazepam60 in 1 BOTTLETABLET602
68788-9207-9Diazepam90 in 1 BOTTLETABLET902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-9207-0EA - Each68788-9207bb355c05-5ba8-465e-82e7-5ff234a4dfff12022-10-06
68788-9207-1EA - Each68788-9207873a14f1-b5ca-4c85-8316-7a6e1080ffb812022-10-06
68788-9207-2EA - Each68788-9207abf19ba1-9013-4989-a9ce-bf9657bdf2a612022-10-06
68788-9207-3EA - Each68788-920794c134ab-1e03-425e-b3c1-6ece235259ba12022-10-06
68788-9207-4EA - Each68788-920719c0d83d-7868-4688-b9fc-1de3561a879312022-10-06
68788-9207-5EA - Each68788-920702a4d054-c6fb-494f-8768-a3b986cc0d1b12022-10-06
68788-9207-6EA - Each68788-92070cdc60e3-7f54-48d4-8fd0-aee604175efe12022-09-12
68788-9207-8EA - Each68788-92073bb9b277-0e65-40bd-b77b-3cdb40b80e7a12022-09-12
68788-9207-9EA - Each68788-92078c2c4f07-d5bf-4324-b129-b705cbf9032a12022-10-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJDIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-9207DIAZEPAM TABLET [PREFERRED PHARMACEUTICALS, INC]2Legacy NDC, 4 package rows20130727_e5f4151c-ee35-4ff7-8374-ab202642373c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNe5f4151c-ee35-4ff7-8374-ab202642373c2
197589diazepam 10 MG Oral TabletSCDe5f4151c-ee35-4ff7-8374-ab202642373c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-9207-0687889207002 TABLET in 1 BOTTLE (68788-9207-0) 2 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-16878892070115 TABLET in 1 BOTTLE (68788-9207-1) 15 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-26878892070220 TABLET in 1 BOTTLE (68788-9207-2) 20 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-36878892070330 TABLET in 1 BOTTLE (68788-9207-3) 30 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-46878892070410 TABLET in 1 BOTTLE (68788-9207-4) 10 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-5687889207056 TABLET in 1 BOTTLE (68788-9207-5) 6 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-66878892070660 TABLET in 1 BOTTLE (68788-9207-6) 60 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-868788920708100 TABLET in 1 BOTTLE (68788-9207-8) 100 tablet2011-11-090000-00-00NoNoCurrent
68788-9207-96878892070990 TABLET in 1 BOTTLE (68788-9207-9) 90 tablet2011-11-090000-00-00NoNoCurrent