temazepam

Product NDC
63187-132
11-digit product format
631870132
Labeler code
63187
Product ID
63187-132_297f2ef3-a614-4992-b087-fe26108471f4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Proficient Rx LP
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
63187-132-30temazepam30 in 1 BOTTLECAPSULE304
63187-132-60temazepam60 in 1 BOTTLECAPSULE604
63187-132-90temazepam90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63187-132-30EA - Each63187-1327534fe59-6397-41e5-b89d-42a61bea6d3612021-04-08

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-132TEMAZEPAM CAPSULE [PROFICIENT RX LP]4Current NDC, Legacy NDC, 3 package rows20230613_904b8986-24da-48eb-bb0a-33d41b4eb005.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN904b8986-24da-48eb-bb0a-33d41b4eb0054
198241temazepam 15 MG Oral CapsuleSCD904b8986-24da-48eb-bb0a-33d41b4eb0054

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-132-306318701323030 CAPSULE in 1 BOTTLE (63187-132-30) 30 capsule2019-01-010000-00-00NoNoCurrent
63187-132-606318701326060 CAPSULE in 1 BOTTLE (63187-132-60) 60 capsule2023-06-08NoNoCurrent
63187-132-906318701329090 CAPSULE in 1 BOTTLE (63187-132-90) 90 capsule2023-06-08NoNoCurrent