Diazepam

Product NDC
10544-161
11-digit product format
105440161
Labeler code
10544
Product ID
10544-161_7785e1b6-c121-4f46-a591-7ddd09a2aeda
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diazepam
Dosage form
TABLET
Route
ORAL
Labeler
Blenheim Pharmacal, Inc.
Application
ANDA077749
Marketing category
ANDA
Marketing start
2010-04-13
Marketing end
0000-00-00
Substance
DIAZEPAM
Active strength
10 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
E
Listing certified through
2017-12-31
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
10544-161-302019-10-29C16284748780-1960f7f55-ce03-8e05-e053-dbdaa90a074aDIAZEPAM TABLETS, USP
10544-161-602019-10-29C16284748780-1960f7f55-ce03-8e05-e053-dbdaa90a074aDIAZEPAM TABLETS, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10544-161-30Diazepam30 in 1 BOTTLETABLET301
10544-161-60Diazepam60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10544-161-30EA - Each10544-161f1789517-cd1f-4748-96ba-cb39b6be8e4912015-02-02
10544-161-60EA - Each10544-1615fff1203-3941-4e9c-9b3f-cb001ec9963412015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIAZEPAMACTIVE INGREDIENTQ3JTX2Q7TUDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
DIAZEPAMACTIVE MOIETYQ3JTX2Q7TUDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XDIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1
SILICON DIOXIDE, COLLOIDALINACTIVE INGREDIENTETJ7Z6XBU4DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10544-161DIAZEPAM TABLET [BLENHEIM PHARMACAL, INC.]1Legacy NDC, 2 package rows20110609_8155c4ef-4ec3-448b-bd60-9b78ad64b53a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197589diazePAM 10 MG Oral TabletPSN8155c4ef-4ec3-448b-bd60-9b78ad64b53a1
197589diazepam 10 MG Oral TabletSCD8155c4ef-4ec3-448b-bd60-9b78ad64b53a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
10544-161-301054401613030 in 1 BOTTLEHistorical
10544-161-601054401616060 in 1 BOTTLEHistorical