FDA.reportPublic FDA data

temazepam

Product NDC
67877-148
11-digit product format
678770148
Labeler code
67877
Product ID
67877-148_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
7.5 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
TEMAZEPAM7.5 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
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-148-01temazepam100 in 1 BOTTLECAPSULE10014
67877-148-05temazepam500 in 1 BOTTLECAPSULE50014
67877-148-30temazepam30 in 1 BOTTLECAPSULE3014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67877-148-01EA - Each67877-1484c2f9e87-f4d3-4c8b-86d4-3774fbaf854a12013-02-19

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 [MAJOR PHARMACEUTICALS]1
temazepamACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
temazepamACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
alcoholINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
ammoniaINACTIVE INGREDIENT5138Q19F1XTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
anhydrous lactoseINACTIVE INGREDIENT3SY5LH9PMKTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
BUTYL ALCOHOLINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
butyl alcoholINACTIVE INGREDIENT8PJ61P6TS3TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOATEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
ferrosoferric oxideINACTIVE INGREDIENTXM0M87F357TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
gelatinINACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
ISOPROPYL ALCOHOLINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
isopropyl alcoholINACTIVE INGREDIENTND2M416302TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
magnesium stearateINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
potassium hydroxideINACTIVE INGREDIENTWZH3C48M4TTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3TEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
shellacINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
SHELLACINACTIVE INGREDIENT46N107B71OTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
starch, cornINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [MAJOR PHARMACEUTICALS]1
titanium dioxideINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [MCKESSON PACKAGING SERVICES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-148TEMAZEPAM 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
198243temazepam 7.5 MG Oral CapsulePSN6559dfee-c29b-4707-8b30-8ca14bf23ea0107
198243temazepam 7.5 MG Oral CapsuleSCD6559dfee-c29b-4707-8b30-8ca14bf23ea0107
198243temazepam 7.5 MG Oral CapsulePSN147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9101
198243temazepam 7.5 MG Oral CapsuleSCD147a51d7-2f8d-43e8-b0ed-a79a2cdfc0a9101
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
198243temazepam 7.5 MG Oral CapsulePSN2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d9
198243temazepam 7.5 MG Oral CapsuleSCD2c4f564d-d349-4f9b-b3f4-f3f0d9706a4d9
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-148-0167877014801100 CAPSULE in 1 BOTTLE (67877-148-01) 100 capsule2012-06-280000-00-00NoNoCurrent
67877-148-0567877014805500 CAPSULE in 1 BOTTLE (67877-148-05) 500 capsule2012-06-280000-00-00NoNoCurrent
67877-148-306787701483030 CAPSULE in 1 BOTTLE (67877-148-30) 30 capsule2012-06-280000-00-00NoNoCurrent