FDA.reportPublic FDA data

Diazepam

Product NDC
33261-717
11-digit product format
332610717
Labeler code
33261
Product ID
33261-717_1288f851-da84-40fb-9b2c-d50c826fe791
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA077749
Marketing category
ANDA
Marketing start
2006-03-31
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
2 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
33261-717-002020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-717-602020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-717-00Diazepam100 in 1 BOTTLE, PLASTICTABLET1001
33261-717-60Diazepam60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-717-00EA - Each33261-717d6f4e4b6-0923-4f39-b151-3d50588034ee12016-09-02
33261-717-60EA - Each33261-71780ba23f3-cc19-4e78-b2f9-d88ad945e33b12015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-717DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 2 package rows20140106_d6ff47b5-bf90-4ce5-8610-b86b5bfc00a9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSNd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91
197590diazePAM 2 MG Oral TabletPSNd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91
197591diazePAM 5 MG Oral TabletPSNd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91
197589diazepam 10 MG Oral TabletSCDd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91
197590diazepam 2 MG Oral TabletSCDd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91
197591diazepam 5 MG Oral TabletSCDd6ff47b5-bf90-4ce5-8610-b86b5bfc00a91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-717-0033261071700100 in 1 BOTTLE, PLASTICHistorical
33261-717-603326107176060 in 1 BOTTLE, PLASTICHistorical