FDA.reportPublic FDA data

temazepam

Product NDC
76420-474
11-digit product format
764200474
Labeler code
76420
Product ID
76420-474_40a62008-e0ba-4776-e063-6394a90a21a3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Asclemed USA, Inc.
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
76420-474-01temazepam100 in 1 BOTTLECAPSULE1002
76420-474-05temazepam500 in 1 BOTTLECAPSULE5002
76420-474-30temazepam30 in 1 BOTTLECAPSULE302
76420-474-60temazepam60 in 1 BOTTLECAPSULE602
76420-474-90temazepam90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-474-01EA - Each76420-474a42aa58d-2fd2-449c-bd25-e3b3960ce9c112025-11-13
76420-474-05EA - Each76420-47477b39b9b-4eaf-419d-a964-e0648bdb6ea612025-11-13
76420-474-30EA - Each76420-474c8bc682c-bd74-45ab-941e-010f3abf262612025-11-13
76420-474-60EA - Each76420-474bb12661e-113f-4b7f-8c40-8460ca60589b12025-11-13
76420-474-90EA - Each76420-474cf039c20-b093-4cac-ace5-5a030ac5b42712025-11-13

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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 startSampleExclude flagStatus
76420-474-0176420047401100 CAPSULE in 1 BOTTLE (76420-474-01) 100 capsule2025-09-18NoNoHistorical
76420-474-0576420047405500 CAPSULE in 1 BOTTLE (76420-474-05) 500 capsule2025-09-18NoNoHistorical
76420-474-307642004743030 CAPSULE in 1 BOTTLE (76420-474-30) 30 capsule2025-09-18NoNoHistorical
76420-474-607642004746060 CAPSULE in 1 BOTTLE (76420-474-60) 60 capsule2025-09-18NoNoHistorical
76420-474-907642004749090 CAPSULE in 1 BOTTLE (76420-474-90) 90 capsule2025-09-18NoNoHistorical