Temazepam

Product NDC
68788-6904
11-digit product format
687886904
Labeler code
68788
Product ID
68788-6904_25483b41-d84a-4eb2-9e86-56d0c58649d9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA203482
Marketing category
ANDA
Marketing start
2017-02-28
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
2018-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68788-6904-1Temazepam100 in 1 BOTTLECAPSULE1001
68788-6904-3Temazepam30 in 1 BOTTLECAPSULE301
68788-6904-6Temazepam60 in 1 BOTTLECAPSULE601
68788-6904-8Temazepam28 in 1 BOTTLECAPSULE281
68788-6904-9Temazepam90 in 1 BOTTLECAPSULE901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-6904TEMAZEPAM CAPSULE [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 5 package rows20170303_25483b41-d84a-4eb2-9e86-56d0c58649d9.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN25483b41-d84a-4eb2-9e86-56d0c58649d91
198242temazepam 30 MG Oral CapsuleSCD25483b41-d84a-4eb2-9e86-56d0c58649d91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-6904-168788690401100 in 1 BOTTLEHistorical
68788-6904-36878869040330 in 1 BOTTLEHistorical
68788-6904-66878869040660 in 1 BOTTLEHistorical
68788-6904-86878869040828 in 1 BOTTLEHistorical
68788-6904-96878869040990 in 1 BOTTLEHistorical