temazepam

Product NDC
63629-8602
11-digit product format
636298602
Labeler code
63629
Product ID
63629-8602_ad63b198-9c80-47d6-a755-dffdbd149c96
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
Active strength
15 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
TEMAZEPAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198241

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
63629-8602-1temazepam100 in 1 BOTTLECAPSULE100102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8602-1EA - Each63629-86022c2eeaec-9af5-442e-ba11-8d510361086612021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8602TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 1 package rows20231104_5dc0c671-3cd8-4e75-9e76-19c1c17b30b2.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN5dc0c671-3cd8-4e75-9e76-19c1c17b30b2102
198241temazepam 15 MG Oral CapsuleSCD5dc0c671-3cd8-4e75-9e76-19c1c17b30b2102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8602-163629860201100 CAPSULE in 1 BOTTLE (63629-8602-1) 100 capsule2021-07-130000-00-00NoNoCurrent