temazepam

Product NDC
50436-4630
11-digit product format
504364630
Labeler code
50436
Product ID
50436-4630_bbc37c80-5793-43c1-bd19-2487dc61fbc8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Unit Dose Services
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
23 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50436-4630-12021-01-29C16284748780-1ba0f9c33-1862-a910-e053-dadaa90a0b85f1ff672d-0b95-4e1b-9104-a545e02f4ee7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-4630-1temazepam30 in 1 BOTTLECAPSULE307

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50436-4630-1EA - Each50436-46306971e5f8-0f34-4637-91a5-2775ccd7230912013-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-4630TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]7Legacy NDC, 1 package rows20170707_f1ff672d-0b95-4e1b-9104-a545e02f4ee7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485489temazepam 22.5 MG Oral CapsulePSNf1ff672d-0b95-4e1b-9104-a545e02f4ee77
485489temazepam 22.5 MG Oral CapsuleSCDf1ff672d-0b95-4e1b-9104-a545e02f4ee77

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-4630-15043646300130 in 1 BOTTLEHistorical