Temazepam

Product NDC
70518-2487
11-digit product format
705182487
Labeler code
70518
Product ID
70518-2487_4df349d4-cb93-33c8-e063-6394a90abeb7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA071620
Marketing category
ANDA
Marketing start
2019-12-16
Substance
TEMAZEPAM
Active strength
15 mg/1
Pharmacologic classes
Benzodiazepine [EPC], Benzodiazepines [CS]
DEA schedule
CIV
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Temazepam
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TEMAZEPAM15 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiCHB1QD2QSS
Rxcui198241

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
70518-2487-0Temazepam100 in 1 BOXCAPSULE10013
70518-2487-1Temazepam1 in 1 POUCHCAPSULE113
70518-2487-2Temazepam30 in 1 BLISTER PACKCAPSULE3013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-2487TEMAZEPAM CAPSULE [REMEDYREPACK INC.]9Current NDC, Legacy NDC, 3 package rows20250426_85919240-0bac-4ed9-97aa-f1aa29be7ffa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSN85919240-0bac-4ed9-97aa-f1aa29be7ffa13
198241temazepam 15 MG Oral CapsuleSCD85919240-0bac-4ed9-97aa-f1aa29be7ffa13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-2487-070518248700100 POUCH in 1 BOX (70518-2487-0) > 1 CAPSULE in 1 POUCH (70518-2487-1) 100 pouch2019-12-160000-00-00NoNoCurrent
70518-2487-1705182487011 in 1 POUCHHistorical
70518-2487-27051824870230 CAPSULE in 1 BLISTER PACK (70518-2487-2) 30 capsule2025-08-13NoNoHistorical