FDA.reportPublic FDA data

temazepam

Product NDC
67877-147
11-digit product format
678770147
Labeler code
67877
Product ID
67877-147_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
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
Rxcui198241, 198242, 198243, 485489

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a3aa44f1-a660-94b4-7185-b48df8b066ffProduct name520250522
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67877-147-01temazepam100 in 1 BOTTLECAPSULE10014
67877-147-05temazepam500 in 1 BOTTLECAPSULE50014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67877-147TEMAZEPAM CAPSULE [ASCEND LABORATORIES, LLC]14Current NDC, Legacy NDC, 2 package rows20231227_8f54731f-c5b7-492c-acb0-444c5fbb7029.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSN5d83e474-0932-49ae-ad92-ca278cd5f1d5105
198242temazepam 30 MG Oral CapsuleSCD5d83e474-0932-49ae-ad92-ca278cd5f1d5105
198242temazepam 30 MG Oral CapsulePSNed068e02-a9c6-41ce-beca-83762720663d104
198242temazepam 30 MG Oral CapsulePSN8af67441-167f-4cc8-a498-c4377ba41c6d104
198242temazepam 30 MG Oral CapsuleSCD8af67441-167f-4cc8-a498-c4377ba41c6d104
198242temazepam 30 MG Oral CapsuleSCDed068e02-a9c6-41ce-beca-83762720663d104
198242temazepam 30 MG Oral CapsulePSN4ae0c582-8b0f-42f9-9b05-f7e1698c5183102
198242temazepam 30 MG Oral CapsuleSCD4ae0c582-8b0f-42f9-9b05-f7e1698c5183102
198242temazepam 30 MG Oral CapsulePSN0e752dda-f00f-4123-b59f-aa911b897a5a100
198242temazepam 30 MG Oral CapsulePSN4fe8192a-0f65-4958-8b6d-e87b9fae9eb5100
198242temazepam 30 MG Oral CapsulePSNbbb6e233-dc6b-43a7-8203-d91421d89921100
198242temazepam 30 MG Oral CapsuleSCDbbb6e233-dc6b-43a7-8203-d91421d89921100
198242temazepam 30 MG Oral CapsuleSCD0e752dda-f00f-4123-b59f-aa911b897a5a100
198242temazepam 30 MG Oral CapsuleSCD4fe8192a-0f65-4958-8b6d-e87b9fae9eb5100
198241temazepam 15 MG Oral CapsulePSN19b2711e-587a-47d2-ab62-d564e7b8719528
198242temazepam 30 MG Oral CapsulePSN19b2711e-587a-47d2-ab62-d564e7b8719528
198241temazepam 15 MG Oral CapsuleSCD19b2711e-587a-47d2-ab62-d564e7b8719528
198242temazepam 30 MG Oral CapsuleSCD19b2711e-587a-47d2-ab62-d564e7b8719528
198242temazepam 30 MG Oral CapsulePSN62379cd5-a314-43eb-a1ee-33997623bfa323
198242temazepam 30 MG Oral CapsuleSCD62379cd5-a314-43eb-a1ee-33997623bfa323
198242temazepam 30 MG Oral CapsulePSN1c08d30d-7c27-a09a-5240-7050771d5cc721
198242temazepam 30 MG Oral CapsuleSCD1c08d30d-7c27-a09a-5240-7050771d5cc721
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
198242temazepam 30 MG Oral CapsulePSN62fc08cd-8143-1652-e053-2a91aa0ad7ed6
198242temazepam 30 MG Oral CapsuleSCD62fc08cd-8143-1652-e053-2a91aa0ad7ed6
198242temazepam 30 MG Oral CapsulePSN7e3fd8fe-fb8a-4577-b540-0e3fefe636275
198242temazepam 30 MG Oral CapsuleSCD7e3fd8fe-fb8a-4577-b540-0e3fefe636275
198241temazepam 15 MG Oral CapsulePSN2ed81194-be24-45a0-8dde-fbc6ad3d7abe4
198241temazepam 15 MG Oral CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsulePSN2ed81194-be24-45a0-8dde-fbc6ad3d7abe4
198242temazepam 30 MG Oral CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198241temazepam 15 MG Oral CapsuleSCD2ed81194-be24-45a0-8dde-fbc6ad3d7abe4
198241temazepam 15 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsuleSCD2ed81194-be24-45a0-8dde-fbc6ad3d7abe4
198242temazepam 30 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994
198241temazepam 15 MG Oral CapsulePSN08183adb-af12-fcb2-e063-6394a90afea43
198242temazepam 30 MG Oral CapsulePSN5aaf8c99-cd58-47fc-8bf5-1039a6315ca53
198242temazepam 30 MG Oral CapsulePSN09e74fd3-223b-4476-86b3-f5eeeb5af3303
198242temazepam 30 MG Oral CapsulePSN08183adb-af12-fcb2-e063-6394a90afea43
198241temazepam 15 MG Oral CapsuleSCD08183adb-af12-fcb2-e063-6394a90afea43
198242temazepam 30 MG Oral CapsuleSCD5aaf8c99-cd58-47fc-8bf5-1039a6315ca53
198242temazepam 30 MG Oral CapsuleSCD09e74fd3-223b-4476-86b3-f5eeeb5af3303
198242temazepam 30 MG Oral CapsuleSCD08183adb-af12-fcb2-e063-6394a90afea43
198241temazepam 15 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198241temazepam 15 MG Oral CapsulePSNccf04879-3ad5-4fc3-89f5-879c978870172
485489temazepam 22.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsulePSNf885bb1a-0445-c452-e053-6394a90ae8aa2
198242temazepam 30 MG Oral CapsulePSNccf04879-3ad5-4fc3-89f5-879c978870172
198243temazepam 7.5 MG Oral CapsulePSN254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198241temazepam 15 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198241temazepam 15 MG Oral CapsuleSCDccf04879-3ad5-4fc3-89f5-879c978870172
485489temazepam 22.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsuleSCDf885bb1a-0445-c452-e053-6394a90ae8aa2
198242temazepam 30 MG Oral CapsuleSCDccf04879-3ad5-4fc3-89f5-879c978870172
198243temazepam 7.5 MG Oral CapsuleSCD254a0273-c0f3-4d2d-b18e-4ab51ba4bc502
198242temazepam 30 MG Oral CapsulePSN09abc9b1-50fc-4c60-a6a1-9772e35b057a1
198242temazepam 30 MG Oral CapsuleSCD09abc9b1-50fc-4c60-a6a1-9772e35b057a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67877-147-0167877014701100 CAPSULE in 1 BOTTLE (67877-147-01) 100 capsule1987-04-210000-00-00NoNoCurrent
67877-147-0567877014705500 CAPSULE in 1 BOTTLE (67877-147-05) 500 capsule1987-04-210000-00-00NoNoCurrent