FDA.reportPublic FDA data

Diazepam

Product NDC
67544-720
11-digit product format
675440720
Labeler code
67544
Product ID
67544-720_d6b6a9b8-aa6a-4b5d-b5ce-564b858d67e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, 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
67544-720-152020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-302020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-452020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-532020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-602020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-702020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-752020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-802020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP
67544-720-902020-01-31C16284748780-19d75b9d0-3c13-f424-e053-dadaa90a57ceDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67544-720-15Diazepam15 in 1 BOTTLE, PLASTICTABLET151
67544-720-30Diazepam30 in 1 BOTTLE, PLASTICTABLET301
67544-720-45Diazepam45 in 1 BOTTLE, PLASTICTABLET451
67544-720-53Diazepam60 in 1 BOTTLE, PLASTICTABLET601
67544-720-60Diazepam90 in 1 BOTTLE, PLASTICTABLET901
67544-720-70Diazepam120 in 1 BOTTLE, PLASTICTABLET1201
67544-720-75Diazepam150 in 1 BOTTLE, PLASTICTABLET1501
67544-720-80Diazepam180 in 1 BOTTLE, PLASTICTABLET1801
67544-720-90Diazepam240 in 1 BOTTLE, PLASTICTABLET2401

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67544-720-15EA - Each67544-720a0bad050-9576-43ee-9816-da26e80e8f9812014-04-03
67544-720-30EA - Each67544-720a9ffe93c-cebd-4ca2-add7-771816e8e0e712014-04-03
67544-720-45EA - Each67544-72029b7055b-33e2-43c8-b1e0-bd90e243fae012014-04-03
67544-720-53EA - Each67544-720c3706081-11d2-4eda-9ca3-a0cc11e6a14112014-04-03
67544-720-60EA - Each67544-72021d36c99-a1b7-4c09-a6c9-fa30f63e4ee512013-05-02
67544-720-70EA - Each67544-7207fa9d2a1-45db-4875-bf2e-9c1f92ace50712013-05-02
67544-720-75EA - Each67544-7202107136d-e770-4fd7-8118-1a1621ec737212014-04-03
67544-720-80EA - Each67544-72066c2386a-e024-4989-81d1-8348b59b14c012014-04-03
67544-720-90EA - Each67544-7202a6287ac-f831-4382-9097-5c76a31abdb912014-04-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67544-720DIAZEPAM TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1Legacy NDC, 9 package rows20130430_52e65341-5fee-4337-be5d-4da91a18f9ac.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN52e65341-5fee-4337-be5d-4da91a18f9ac1
197589diazepam 10 MG Oral TabletSCD52e65341-5fee-4337-be5d-4da91a18f9ac1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
67544-720-156754407201515 in 1 BOTTLE, PLASTICHistorical
67544-720-306754407203030 in 1 BOTTLE, PLASTICHistorical
67544-720-456754407204545 in 1 BOTTLE, PLASTICHistorical
67544-720-536754407205360 in 1 BOTTLE, PLASTICHistorical
67544-720-606754407206090 in 1 BOTTLE, PLASTICHistorical
67544-720-7067544072070120 in 1 BOTTLE, PLASTICHistorical
67544-720-7567544072075150 in 1 BOTTLE, PLASTICHistorical
67544-720-8067544072080180 in 1 BOTTLE, PLASTICHistorical
67544-720-9067544072090240 in 1 BOTTLE, PLASTICHistorical