temazepam

Product NDC
21695-282
11-digit product format
216950282
Labeler code
21695
Product ID
21695-282_6979644e-0587-4040-b754-5dce5eda87a4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Rebel Distributors Corp
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-282-302019-09-24C16284748780-1934fe258-4bb1-48b1-e053-8cdaa90a720aTemazepam
21695-282-602019-09-24C16284748780-1934fe258-4bb1-48b1-e053-8cdaa90a720aTemazepam
21695-282-782019-09-24C16284748780-1934fe258-4bb1-48b1-e053-8cdaa90a720aTemazepam

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-282-30temazepam30 in 1 BOTTLECAPSULE301
21695-282-60temazepam60 in 1 BOTTLECAPSULE601
21695-282-78temazepam180 in 1 BOTTLECAPSULE1801

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
21695-282-30EA - Each21695-28267dd39e7-6b39-4859-90be-e0592f4a90db12012-07-24
21695-282-60EA - Each21695-28276ab4640-c750-42af-86dc-aa95df949efb12012-07-24
21695-282-78EA - Each21695-282d7102a18-8558-4cbc-842c-b8293729d0de12012-07-24

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
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 5INACTIVE INGREDIENTI753WB2F1MTEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM 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
21695-282TEMAZEPAM CAPSULE [REBEL DISTRIBUTORS CORP]1Legacy NDC, 3 package rows20101210_6979644e-0587-4040-b754-5dce5eda87a4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN6979644e-0587-4040-b754-5dce5eda87a41
198241temazepam 15 MG Oral CapsuleSCD6979644e-0587-4040-b754-5dce5eda87a41

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
21695-282-302169502823030 in 1 BOTTLEHistorical
21695-282-602169502826060 in 1 BOTTLEHistorical
21695-282-7821695028278180 in 1 BOTTLEHistorical