temazepam

Product NDC
53217-205
11-digit product format
532170205
Labeler code
53217
Product ID
53217-205_8fdf3507-3800-45ee-8074-48b090b4d92c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
23 mg/1
Pharmacologic classes
Benzodiazepine [EPC],Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2019-12-31
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
53217-205-302020-01-31C16284748780-19d75b9d0-832c-f424-e053-dadaa90a57ceTemazepam, USP
53217-205-602020-01-31C16284748780-19d75b9d0-832c-f424-e053-dadaa90a57ceTemazepam, USP
53217-205-902020-01-31C16284748780-19d75b9d0-832c-f424-e053-dadaa90a57ceTemazepam, USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-205-30temazepam30 in 1 BOTTLECAPSULE301
53217-205-60temazepam60 in 1 BOTTLECAPSULE601
53217-205-90temazepam90 in 1 BOTTLECAPSULE901

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-205-30EA - Each53217-205bb7a36e8-1f53-476c-82e9-7cc1e3b170c112017-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-205TEMAZEPAM CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 3 package rows20170331_7e9c51d4-032b-48ab-9c19-6050d1e86512.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485489temazepam 22.5 MG Oral CapsulePSN7e9c51d4-032b-48ab-9c19-6050d1e865121
485489temazepam 22.5 MG Oral CapsuleSCD7e9c51d4-032b-48ab-9c19-6050d1e865121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-205-305321702053030 in 1 BOTTLEHistorical
53217-205-605321702056060 in 1 BOTTLEHistorical
53217-205-905321702059090 in 1 BOTTLEHistorical