FDA.reportPublic FDA data

Temazepam

Product NDC
0228-2077
11-digit product format
002282077
Labeler code
0228
Product ID
0228-2077_3050ee1e-c494-48ce-be40-6424e9661d87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA071620
Marketing category
ANDA
Marketing start
1990-09-30
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
Rxcui198241, 198242

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
351abe41-466c-4dd8-840a-0fdb68318bd5Product name120230316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0228-2077-10Temazepam100 in 1 BOTTLECAPSULE10025
0228-2077-50Temazepam500 in 1 BOTTLECAPSULE50025

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0228-2077-10EA - Each0228-2077c764fecc-8ee8-462b-8762-59e2b0f09ffe12013-02-13
0228-2077-50EA - Each0228-20774a8735e6-3b5f-464a-8cd3-7a630104848d12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A8TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [ACTAVIS ELIZABETH LLC]5
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [UNIT DOSE SERVICES]3
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM 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
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECT RX]1
TEMAZEPAMACTIVE INGREDIENTCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [DIRECT RX]1
TEMAZEPAMACTIVE MOIETYCHB1QD2QSSTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [DIRECT RX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3GTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
FD&C GREEN NO. 3INACTIVE INGREDIENT3P3ONR6O1STEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
GELATININACTIVE INGREDIENT2G86QN327LTEMAZEPAM CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [DIRECT RX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM CAPSULE [DIRECT RX]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [DIRECT RX]1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141JTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [DIRECT RX]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPTEMAZEPAM CAPSULE [DIRECT RX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0228-2077TEMAZEPAM CAPSULE [ACTAVIS PHARMA, INC.]24Current NDC, Legacy NDC, 2 package rows20250213_a4370eb4-b00d-4247-af8d-980e59fbbec6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNa4370eb4-b00d-4247-af8d-980e59fbbec625
198242temazepam 30 MG Oral CapsulePSNa4370eb4-b00d-4247-af8d-980e59fbbec625
198241temazepam 15 MG Oral CapsuleSCDa4370eb4-b00d-4247-af8d-980e59fbbec625
198242temazepam 30 MG Oral CapsuleSCDa4370eb4-b00d-4247-af8d-980e59fbbec625
198242temazepam 30 MG Oral CapsulePSNbecd63c1-5d14-4578-9f1e-df583f18a8189
198242temazepam 30 MG Oral CapsuleSCDbecd63c1-5d14-4578-9f1e-df583f18a8189
198242temazepam 30 MG Oral CapsulePSN5de3751c-66d8-4b77-8698-12b67aa5f9e85
198242temazepam 30 MG Oral CapsuleSCD5de3751c-66d8-4b77-8698-12b67aa5f9e85
198242temazepam 30 MG Oral CapsulePSN617d1957-c414-7f34-e053-2a91aa0a3fe04
198242temazepam 30 MG Oral CapsuleSCD617d1957-c414-7f34-e053-2a91aa0a3fe04
198241temazepam 15 MG Oral CapsulePSN2461dfbd-5704-42f4-bde7-d1461811d8982
198242temazepam 30 MG Oral CapsulePSN2461dfbd-5704-42f4-bde7-d1461811d8982
198241temazepam 15 MG Oral CapsuleSCD2461dfbd-5704-42f4-bde7-d1461811d8982
198242temazepam 30 MG Oral CapsuleSCD2461dfbd-5704-42f4-bde7-d1461811d8982

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0228-2077-1000228207710100 CAPSULE in 1 BOTTLE (0228-2077-10) 100 capsule1990-09-300000-00-00NoNoCurrent
0228-2077-5000228207750500 CAPSULE in 1 BOTTLE (0228-2077-50) 500 capsule1990-09-300000-00-00NoNoCurrent