temazepam

Product NDC
63629-8603
11-digit product format
636298603
Labeler code
63629
Product ID
63629-8603_9701f9a2-eb4c-42c9-82b1-1ceaf549356e
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
63629-8603-1temazepam500 in 1 BOTTLECAPSULE500106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-8603-1EA - Each63629-8603f10cf13f-cb57-4068-866f-7985cc2914c412021-10-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-8603TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]106Current NDC, Legacy NDC, 1 package rows20240814_a90d9165-da54-48e5-b144-ebeb6ff8d8ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNa90d9165-da54-48e5-b144-ebeb6ff8d8ab106
198241temazepam 15 MG Oral CapsuleSCDa90d9165-da54-48e5-b144-ebeb6ff8d8ab106

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-8603-163629860301500 CAPSULE in 1 BOTTLE (63629-8603-1) 500 capsule2021-07-130000-00-00NoNoCurrent