temazepam

Product NDC
63739-003
11-digit product format
637390003
Labeler code
63739
Product ID
63739-003_dd440bb6-970d-cf9e-e053-2a95a90ab82a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
McKesson Corporation dba SKY Packaging
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
8 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2023-12-31
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
63739-003-332020-07-22C16284748780-1ab0e2407-2d48-f274-e053-dbdaa90a6471MCK - Temazepam - Ascend

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63739-003-33EA - Each63739-0038bd7a8ca-7fc5-4fa3-bc32-478167f4f78312015-12-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63739-003TEMAZEPAM CAPSULE [MCKESSON CORPORATION DBA SKY PACKAGING]15Legacy NDC20250115_aeaa1606-a75f-44ad-99de-56567fcc40dc.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63739-003-33637390003333 BLISTER PACK in 1 BOX, UNIT-DOSE (63739-003-33) > 10 CAPSULE in 1 BLISTER PACK3 blister pack2015-11-040000-00-00NoNoCurrent