Temazepam

Product NDC
71335-2043
11-digit product format
713352043
Labeler code
71335
Product ID
71335-2043_28230ade-ea7a-4fc1-a654-61bc7fe9afc1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA211542
Marketing category
ANDA
Marketing start
2018-11-27
Substance
TEMAZEPAM
Active strength
22.5 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Temazepam
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM22.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui485489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2043-1Temazepam30 in 1 BOTTLECAPSULE30101

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2043-1EA - Each71335-2043a3319451-e9b1-4cf0-b5c4-607e55d3070e12023-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2043TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]101Current NDC, Legacy NDC, 1 package rows20231123_74a3db09-94d0-45e1-8c68-da7ca49d3d59.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485489temazepam 22.5 MG Oral CapsulePSN74a3db09-94d0-45e1-8c68-da7ca49d3d59101
485489temazepam 22.5 MG Oral CapsuleSCD74a3db09-94d0-45e1-8c68-da7ca49d3d59101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-2043-17133520430130 CAPSULE in 1 BOTTLE (71335-2043-1) 30 capsule2022-02-100000-00-00NoNoCurrent