FDA.reportPublic FDA data

temazepam

Product NDC
67877-149
11-digit product format
678770149
Labeler code
67877
Product ID
67877-149_45d37c04-846d-4f50-ac42-52b2d051d115
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Ascend Laboratories, LLC
Application
ANDA071457
Marketing category
ANDA
Marketing start
2012-06-28
Substance
TEMAZEPAM
Active strength
22.5 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
TEMAZEPAM22.5 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198241, 198242, 198243, 485489

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
67877-149-01temazepam100 in 1 BOTTLECAPSULE10014
67877-149-05temazepam500 in 1 BOTTLECAPSULE50014
67877-149-30temazepam30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-149-30EA - Each67877-149def84b23-69af-40c5-b4a2-5a71fd575b8912013-02-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]10
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
AMMONIAINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-149TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]14Current NDC, Legacy NDC, 3 package rows20231227_8f54731f-c5b7-492c-acb0-444c5fbb7029.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
485489temazepam 22.5 MG Oral CapsulePSN1e37d59b-b8be-46ef-8706-fffd563a8c15102
485489temazepam 22.5 MG Oral CapsuleSCD1e37d59b-b8be-46ef-8706-fffd563a8c15102
485489temazepam 22.5 MG Oral CapsulePSNdadc2f66-7fa5-4be4-a9d0-d96e5836f550101
485489temazepam 22.5 MG Oral CapsuleSCDdadc2f66-7fa5-4be4-a9d0-d96e5836f550101
198241temazepam 15 MG Oral CapsulePSN8f54731f-c5b7-492c-acb0-444c5fbb702914
485489temazepam 22.5 MG Oral CapsulePSN8f54731f-c5b7-492c-acb0-444c5fbb702914
198242temazepam 30 MG Oral CapsulePSN8f54731f-c5b7-492c-acb0-444c5fbb702914
198243temazepam 7.5 MG Oral CapsulePSN8f54731f-c5b7-492c-acb0-444c5fbb702914
198241temazepam 15 MG Oral CapsuleSCD8f54731f-c5b7-492c-acb0-444c5fbb702914
485489temazepam 22.5 MG Oral CapsuleSCD8f54731f-c5b7-492c-acb0-444c5fbb702914
198242temazepam 30 MG Oral CapsuleSCD8f54731f-c5b7-492c-acb0-444c5fbb702914
198243temazepam 7.5 MG Oral CapsuleSCD8f54731f-c5b7-492c-acb0-444c5fbb702914
485489temazepam 22.5 MG Oral CapsulePSNf1ff672d-0b95-4e1b-9104-a545e02f4ee77
485489temazepam 22.5 MG Oral CapsuleSCDf1ff672d-0b95-4e1b-9104-a545e02f4ee77
198241temazepam 15 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
485489temazepam 22.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198243temazepam 7.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198241temazepam 15 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
485489temazepam 22.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198243temazepam 7.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
485489temazepam 22.5 MG Oral CapsulePSN7e9c51d4-032b-48ab-9c19-6050d1e865121
485489temazepam 22.5 MG Oral CapsuleSCD7e9c51d4-032b-48ab-9c19-6050d1e865121

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-149-0167877014901100 CAPSULE in 1 BOTTLE (67877-149-01) 100 capsule2012-06-280000-00-00NoNoCurrent
67877-149-0567877014905500 CAPSULE in 1 BOTTLE (67877-149-05) 500 capsule2012-06-280000-00-00NoNoCurrent
67877-149-306787701493030 CAPSULE in 1 BOTTLE (67877-149-30) 30 capsule2012-06-280000-00-00NoNoCurrent