temazepam

Product NDC
63629-8601
11-digit product format
636298601
Labeler code
63629
Product ID
63629-8601_63a2c9e8-1fdb-4534-8c68-cafb4cf72f92
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
7.5 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
TEMAZEPAM7.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198243

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
63629-8601-1temazepam100 in 1 BOTTLECAPSULE100107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8601-1EA - Each63629-86018cfa6964-ee11-4cae-a584-59dacf9aaf1312021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8601TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]107Current NDC, Legacy NDC, 1 package rows20240806_6559dfee-c29b-4707-8b30-8ca14bf23ea0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198243temazepam 7.5 MG Oral CapsulePSN6559dfee-c29b-4707-8b30-8ca14bf23ea0107
198243temazepam 7.5 MG Oral CapsuleSCD6559dfee-c29b-4707-8b30-8ca14bf23ea0107

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8601-163629860101100 CAPSULE in 1 BOTTLE (63629-8601-1) 100 capsule2021-07-130000-00-00NoNoCurrent