temazepam

Product NDC
63629-8604
11-digit product format
636298604
Labeler code
63629
Product ID
63629-8604_bb2354c0-ae61-4be3-bec7-fa29df33a100
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63629-8604-1temazepam30 in 1 BOTTLECAPSULE30102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8604-1EA - Each63629-86045b175b92-ef82-466e-80d9-81a61fa1683012021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8604TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20240113_1e37d59b-b8be-46ef-8706-fffd563a8c15.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485489temazepam 22.5 MG Oral CapsulePSN1e37d59b-b8be-46ef-8706-fffd563a8c15102
485489temazepam 22.5 MG Oral CapsuleSCD1e37d59b-b8be-46ef-8706-fffd563a8c15102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8604-16362986040130 CAPSULE in 1 BOTTLE (63629-8604-1) 30 capsule2021-07-130000-00-00NoNoCurrent