TEMAZEPAM

Product NDC
61919-263
11-digit product format
619190263
Labeler code
61919
Product ID
61919-263_7bc99758-11bc-4b1d-96a4-a30926d9dfd2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TEMAZEPAM
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
ANDA071456
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
15 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
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-263-302020-01-31C16284748780-19d75b9cf-f617-f424-e053-dadaa90a57ceTEMAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-263-30TEMAZEPAM30 in 1 BOTTLECAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
61919-263-30EA - Each61919-263051b866f-2781-4af4-aeae-286ecdf3e2f412016-09-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECTRX]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECTRX]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [DIRECTRX]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [DIRECTRX]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [DIRECTRX]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [DIRECTRX]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [DIRECTRX]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [DIRECTRX]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [DIRECTRX]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [DIRECTRX]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [DIRECTRX]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [DIRECTRX]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [DIRECTRX]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [DIRECTRX]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [DIRECTRX]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [DIRECTRX]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [DIRECTRX]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-263TEMAZEPAM CAPSULE [DIRECTRX]1Legacy NDC, 1 package rows20151027_f7c31cab-c96b-45e1-8c29-48e17b3fd731.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNf7c31cab-c96b-45e1-8c29-48e17b3fd7311
198241temazepam 15 MG Oral CapsuleSCDf7c31cab-c96b-45e1-8c29-48e17b3fd7311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
61919-263-306191902633030 in 1 BOTTLEHistorical