FDA.reportPublic FDA data

temazepam

Product NDC
55289-660
11-digit product format
552890660
Labeler code
55289
Product ID
55289-660_419b1d3a-0d95-2e95-e063-6294a90a2123
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55289-660-01temazepam100 in 1 BOTTLE, PLASTICCAPSULE10023
55289-660-30temazepam30 in 1 BOTTLE, PLASTICCAPSULE3023
55289-660-60temazepam60 in 1 BOTTLE, PLASTICCAPSULE6023
55289-660-82temazepam500 in 1 BOTTLE, PLASTICCAPSULE50023
55289-660-90temazepam90 in 1 BOTTLE, PLASTICCAPSULE9023

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55289-660-01EA - Each55289-6602a20e418-1caa-4d43-ae7d-788ec464511412018-08-13
55289-660-30EA - Each55289-6609a5cacf4-be07-4fba-94b0-a8c1a9b4939012012-07-24
55289-660-60EA - Each55289-66018a84435-2c83-4b89-b446-8103c0b55b2d12016-03-04
55289-660-82EA - Each55289-660f9f1dd32-e3db-42af-955a-dce0e2f2727d12020-05-08
55289-660-90EA - Each55289-660d41309ff-1797-4e32-8f54-595fc8f1fd3f12016-03-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM (TEMAZEPAM) CAPSULE [PD-RX PHARMACEUTICALS, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55289-660TEMAZEPAM CAPSULE [PD-RX PHARMACEUTICALS, INC.]22Current NDC, Legacy NDC, 5 package rows20241012_62379cd5-a314-43eb-a1ee-33997623bfa3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN62379cd5-a314-43eb-a1ee-33997623bfa323
198242temazepam 30 MG Oral CapsuleSCD62379cd5-a314-43eb-a1ee-33997623bfa323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55289-660-0155289066001100 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-01) 100 capsule2016-01-210000-00-00NoNoCurrent
55289-660-305528906603030 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-30) 30 capsule2016-01-210000-00-00NoNoCurrent
55289-660-605528906606060 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-60) 60 capsule2016-01-210000-00-00NoNoCurrent
55289-660-8255289066082500 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-82) 500 capsule2020-04-200000-00-00NoNoCurrent
55289-660-905528906609090 CAPSULE in 1 BOTTLE, PLASTIC (55289-660-90) 90 capsule2016-01-210000-00-00NoNoCurrent