temazepam

Product NDC
50090-0186
11-digit product format
500900186
Labeler code
50090
Product ID
50090-0186_ad92d05a-be04-429f-8aed-e87b61cdf598
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
A-S Medication Solutions
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, 198242

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-0186-0temazepam30 in 1 BOTTLECAPSULE3028

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-0186-0EA - Each50090-0186a3226f15-bc5f-4b47-8ce5-9723ac5513a612018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-0186TEMAZEPAM CAPSULE [A-S MEDICATION SOLUTIONS]24Current NDC, Legacy NDC, 1 package rows20230306_19b2711e-587a-47d2-ab62-d564e7b87195.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN19b2711e-587a-47d2-ab62-d564e7b8719528
198242temazepam 30 MG Oral CapsulePSN19b2711e-587a-47d2-ab62-d564e7b8719528
198241temazepam 15 MG Oral CapsuleSCD19b2711e-587a-47d2-ab62-d564e7b8719528
198242temazepam 30 MG Oral CapsuleSCD19b2711e-587a-47d2-ab62-d564e7b8719528

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-0186-05009001860030 CAPSULE in 1 BOTTLE (50090-0186-0) 30 capsule2014-11-280000-00-00NoNoCurrent