temazepam

Product NDC
63629-1057
11-digit product format
636291057
Labeler code
63629
Product ID
63629-1057_a11a6ac3-61ee-4104-b037-e4b854fe38cf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA071457
Marketing category
ANDA
Marketing start
1987-04-21
Substance
TEMAZEPAM
Active strength
30 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
TEMAZEPAM30 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198242

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
63629-1057-1temazepam500 in 1 BOTTLECAPSULE50021

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1057TEMAZEPAM CAPSULE [BRYANT RANCH PREPACK]21Current NDC, Legacy NDC, 1 package rows20240111_1c08d30d-7c27-a09a-5240-7050771d5cc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN1c08d30d-7c27-a09a-5240-7050771d5cc721
198242temazepam 30 MG Oral CapsuleSCD1c08d30d-7c27-a09a-5240-7050771d5cc721

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1057-163629105701500 CAPSULE in 1 BOTTLE (63629-1057-1) 500 capsule2021-12-210000-00-00NoNoCurrent