FDA.reportPublic FDA data

TEMAZEPAM

Product NDC
71610-626
11-digit product format
716100626
Labeler code
71610
Product ID
71610-626_1b2a670e-edfd-4ce9-e063-6294a90aaf23
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
NDA018163
Marketing category
NDA
Marketing start
2010-02-23
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71610-626-15TEMAZEPAM15 in 1 BOTTLECAPSULE154
71610-626-28TEMAZEPAM28 in 1 BOTTLECAPSULE284
71610-626-30TEMAZEPAM30 in 1 BOTTLECAPSULE304
71610-626-53TEMAZEPAM60 in 1 BOTTLECAPSULE604
71610-626-60TEMAZEPAM90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-626-15EA - Each71610-626fc09c5d3-be09-4cb9-afcc-1dcd09a0410c12022-03-09
71610-626-28EA - Each71610-62674de4af1-095e-4470-90b5-67ae830fa81e12024-05-16
71610-626-30EA - Each71610-62643c999ee-b389-48de-a0aa-45fe9484071b12022-03-09
71610-626-53EA - Each71610-626310657c2-588d-4f70-8213-5e0d5a974fe412022-03-09
71610-626-60EA - Each71610-626539841ae-55b0-45a0-9ab4-965821ebd6f312024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-626TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]4Current NDC, Legacy NDC, 5 package rows20240625_a8deb28b-c5a3-4775-8bec-3f276698d064.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNa8deb28b-c5a3-4775-8bec-3f276698d0644
198242temazepam 30 MG Oral CapsulePSNa8deb28b-c5a3-4775-8bec-3f276698d0644
198241temazepam 15 MG Oral CapsuleSCDa8deb28b-c5a3-4775-8bec-3f276698d0644
198242temazepam 30 MG Oral CapsuleSCDa8deb28b-c5a3-4775-8bec-3f276698d0644

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71610-626-157161006261515 CAPSULE in 1 BOTTLE (71610-626-15) 15 capsule2021-12-100000-00-00NoNoCurrent
71610-626-287161006262828 CAPSULE in 1 BOTTLE (71610-626-28) 28 capsule2024-03-07NoNoCurrent
71610-626-307161006263030 CAPSULE in 1 BOTTLE (71610-626-30) 30 capsule2021-12-100000-00-00NoNoCurrent
71610-626-537161006265360 CAPSULE in 1 BOTTLE (71610-626-53) 60 capsule2021-12-100000-00-00NoNoCurrent
71610-626-607161006266090 CAPSULE in 1 BOTTLE (71610-626-60) 90 capsule2024-02-29NoNoCurrent