FDA.reportPublic FDA data

Diazepam

Product NDC
33261-034
11-digit product format
332610034
Labeler code
33261
Product ID
33261-034_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
5 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
33261-034-052020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-072020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-102020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-142020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-292020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-302020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-312020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-602020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-034-902020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-034-05Diazepam5 in 1 BOTTLE, PLASTICTABLET51
33261-034-07Diazepam7 in 1 BOTTLE, PLASTICTABLET71
33261-034-10Diazepam10 in 1 BOTTLE, PLASTICTABLET101
33261-034-14Diazepam14 in 1 BOTTLE, PLASTICTABLET141
33261-034-29Diazepam2 in 1 BOTTLE, PLASTICTABLET21
33261-034-30Diazepam30 in 1 BOTTLE, PLASTICTABLET301
33261-034-31Diazepam3 in 1 BOTTLE, PLASTICTABLET31
33261-034-60Diazepam60 in 1 BOTTLE, PLASTICTABLET601
33261-034-90Diazepam90 in 1 BOTTLE, PLASTICTABLET901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-034-07EA - Each33261-0341311a72a-59a1-4b24-b732-0b13e83676c012015-10-02
33261-034-14EA - Each33261-0348c093679-9632-4290-8806-f07f237eced812015-10-02
33261-034-29EA - Each33261-034b98c1ff7-2d82-448c-b968-36013fc36d1212015-10-02
33261-034-30EA - Each33261-03474e7e76a-b906-4b63-9407-a4e356af52db12015-10-02
33261-034-60EA - Each33261-034930302e7-57cc-4fa1-93d6-932ecd71eb7a12015-10-02
33261-034-90EA - Each33261-034fd870968-de37-4374-9e61-87df06fa0d6d12015-10-02

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
33261-034DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 9 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
33261-034-05332610034055 in 1 BOTTLE, PLASTICHistorical
33261-034-07332610034077 in 1 BOTTLE, PLASTICHistorical
33261-034-103326100341010 in 1 BOTTLE, PLASTICHistorical
33261-034-143326100341414 in 1 BOTTLE, PLASTICHistorical
33261-034-29332610034292 in 1 BOTTLE, PLASTICHistorical
33261-034-303326100343030 in 1 BOTTLE, PLASTICHistorical
33261-034-31332610034313 in 1 BOTTLE, PLASTICHistorical
33261-034-603326100346060 in 1 BOTTLE, PLASTICHistorical
33261-034-903326100349090 in 1 BOTTLE, PLASTICHistorical