FDA.reportPublic FDA data

Diazepam

Product NDC
33261-035
11-digit product format
332610035
Labeler code
33261
Product ID
33261-035_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
10 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
33261-035-052020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-072020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-082020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-102020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-202020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-302020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
33261-035-602020-01-31C16284748780-19d75b9d0-760f-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-035-05Diazepam5 in 1 BOTTLE, PLASTICTABLET51
33261-035-07Diazepam7 in 1 BOTTLE, PLASTICTABLET71
33261-035-08Diazepam8 in 1 BOTTLE, PLASTICTABLET81
33261-035-10Diazepam10 in 1 BOTTLE, PLASTICTABLET101
33261-035-20Diazepam20 in 1 BOTTLE, PLASTICTABLET201
33261-035-30Diazepam30 in 1 BOTTLE, PLASTICTABLET301
33261-035-60Diazepam60 in 1 BOTTLE, PLASTICTABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-035-05EA - Each33261-0358c6a1484-1e2c-4926-ac49-bad2e2026a8612015-10-02

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
33261-035DIAZEPAM TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 7 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
33261-035-05332610035055 in 1 BOTTLE, PLASTICHistorical
33261-035-07332610035077 in 1 BOTTLE, PLASTICHistorical
33261-035-08332610035088 in 1 BOTTLE, PLASTICHistorical
33261-035-103326100351010 in 1 BOTTLE, PLASTICHistorical
33261-035-203326100352020 in 1 BOTTLE, PLASTICHistorical
33261-035-303326100353030 in 1 BOTTLE, PLASTICHistorical
33261-035-603326100356060 in 1 BOTTLE, PLASTICHistorical