Temazepam

Product NDC
33261-101
11-digit product format
332610101
Labeler code
33261
Product ID
33261-101_bbcc0af6-39fc-4c3c-8644-a773a0f0c611
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA070920
Marketing category
ANDA
Marketing start
2017-12-18
Marketing end
0000-00-00
Substance
TEMAZEPAM
Active strength
15 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
33261-101-302020-01-31C16284748780-19d75b9d0-8f65-f424-e053-dadaa90a57ceTemazepam USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33261-101-30Temazepam30 in 1 BOTTLE, PLASTICCAPSULE301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33261-101-30EA - Each33261-10132563983-f4c1-48dd-9076-f54e8eb6bf0912018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33261-101TEMAZEPAM CAPSULE [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180817_c6053e97-1642-4da3-8dcb-f3858f5db963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNc6053e97-1642-4da3-8dcb-f3858f5db9631
198241temazepam 15 MG Oral CapsuleSCDc6053e97-1642-4da3-8dcb-f3858f5db9631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
33261-101-303326101013030 in 1 BOTTLE, PLASTICHistorical