Temazepam

Product NDC
51407-507
11-digit product format
514070507
Labeler code
51407
Product ID
51407-507_1ddc264f-f08e-cfbf-e063-6394a90aeda3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Golden State Medical Supply, Inc.
Application
ANDA211542
Marketing category
ANDA
Marketing start
2018-11-23
Substance
TEMAZEPAM
Active strength
15 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
TEMAZEPAM15 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-507-05Temazepam500 in 1 BOTTLECAPSULE5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-507-05EA - Each51407-5071942c97b-e480-4b26-9eb4-ab190c59402f12024-08-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51407-507TEMAZEPAM CAPSULE [GOLDEN STATE MEDICAL SUPPLY, INC.]1Current NDC, 1 package rows20240724_1ddc31b7-2b23-fb10-e063-6394a90a55f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN1ddc31b7-2b23-fb10-e063-6394a90a55f31
198242temazepam 30 MG Oral CapsulePSN1ddc31b7-2b23-fb10-e063-6394a90a55f31
198241temazepam 15 MG Oral CapsuleSCD1ddc31b7-2b23-fb10-e063-6394a90a55f31
198242temazepam 30 MG Oral CapsuleSCD1ddc31b7-2b23-fb10-e063-6394a90a55f31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51407-507-0551407050705500 CAPSULE in 1 BOTTLE (51407-507-05) 500 capsule2024-06-05NoNoCurrent