temazepam

Product NDC
21695-283
11-digit product format
216950283
Labeler code
21695
Product ID
21695-283_09abc9b1-50fc-4c60-a6a1-9772e35b057a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA071457
Marketing category
ANDA
Marketing start
1987-04-21
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
30 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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-283-302019-09-24C16284748780-1934fe258-4b63-48b1-e053-8cdaa90a720aTemazepam
21695-283-902019-09-24C16284748780-1934fe258-4b63-48b1-e053-8cdaa90a720aTemazepam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-283-30temazepam30 in 1 BOTTLECAPSULE301
21695-283-90temazepam90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-283-30EA - Each21695-283e05a01f7-5a82-4afb-b8d6-b6707f6d561412012-07-24
21695-283-90EA - Each21695-283e89f2f44-0e55-4055-bd57-c174d901bfa612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
benzyl alcoholINACTIVE INGREDIENTLKG8494WBHTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
butylparabenINACTIVE INGREDIENT3QPI1U3FV8TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
edetate calcium disodiumINACTIVE INGREDIENT25IH6R4SGFTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
sodium propionateINACTIVE INGREDIENTDK6Y9P42INTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-283TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20101210_09abc9b1-50fc-4c60-a6a1-9772e35b057a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN09abc9b1-50fc-4c60-a6a1-9772e35b057a1
198242temazepam 30 MG Oral CapsuleSCD09abc9b1-50fc-4c60-a6a1-9772e35b057a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-283-302169502833030 in 1 BOTTLEHistorical
21695-283-902169502839090 in 1 BOTTLEHistorical