TEMAZEPAM

Product NDC
61919-264
11-digit product format
619190264
Labeler code
61919
Product ID
61919-264_a8261a8c-cf26-d681-e053-2995a90a60ab
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
TEMAZEPAM
Dosage form
CAPSULE
Route
ORAL
Labeler
DirectRX
Application
ANDA071457
Marketing category
ANDA
Marketing start
2015-01-01
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
30 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2021-12-31
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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
61919-264-302025-01-30C16284748780-19d75b9d0-4ee2-f424-e053-dadaa90a57ceTEMAZEPAM
61919-264-302020-06-16C16284748780-19d75b9d0-4ee2-f424-e053-dadaa90a57ceTEMAZEPAM
61919-264-302020-01-31C16284748780-19d75b9d0-4ee2-f424-e053-dadaa90a57ceTEMAZEPAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61919-264-30TEMAZEPAM30 in 1 BOTTLECAPSULE303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61919-264TEMAZEPAM CAPSULE [DIRECTRX]3Legacy NDC, 1 package rows20200617_09e74fd3-223b-4476-86b3-f5eeeb5af330.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN09e74fd3-223b-4476-86b3-f5eeeb5af3303
198242temazepam 30 MG Oral CapsuleSCD09e74fd3-223b-4476-86b3-f5eeeb5af3303

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
61919-264-306191902643030 CAPSULE in 1 BOTTLE (61919-264-30) 30 capsule2015-01-010000-00-00NoNoCurrent