FDA.reportPublic FDA data

temazepam

Product NDC
43353-312
11-digit product format
433530312
Labeler code
43353
Product ID
43353-312_ec1b0a54-5f93-45ed-bbbf-0bf3cd42ba73
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA071456
Marketing category
ANDA
Marketing start
1987-04-21
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
43353-312-10temazepam10 in 1 BOTTLECAPSULE104
43353-312-15temazepam15 in 1 BOTTLECAPSULE154
43353-312-28temazepam28 in 1 BOTTLECAPSULE284
43353-312-30temazepam30 in 1 BOTTLECAPSULE304
43353-312-45temazepam45 in 1 BOTTLECAPSULE454
43353-312-53temazepam60 in 1 BOTTLECAPSULE604
43353-312-60temazepam90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43353-312-10EA - Each43353-31268b27f60-e2b3-419e-938f-4677089391d612024-05-16
43353-312-15EA - Each43353-312b2e5ab1f-1968-43f4-b86e-8c08ca535f4a12018-08-13
43353-312-28EA - Each43353-31295c6a410-3e5a-4e9d-82cd-6afdec25d57112024-04-05
43353-312-30EA - Each43353-3120022eab2-256b-4177-b736-ab041c7de61812017-11-06
43353-312-45EA - Each43353-3126bca5710-a9c0-4851-a714-d4732fdbb43b12018-10-11
43353-312-53EA - Each43353-3126ca70961-904f-411d-8d02-9f2a8866835c12017-11-06
43353-312-60EA - Each43353-3122a450ff3-1c9d-47ab-9921-a5449ec995e712017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43353-312TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 7 package rows20240124_b2422ca0-2f06-419f-aa0e-88c556b62399.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198241temazepam 15 MG Oral CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsulePSNb2422ca0-2f06-419f-aa0e-88c556b623994
198241temazepam 15 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994
198242temazepam 30 MG Oral CapsuleSCDb2422ca0-2f06-419f-aa0e-88c556b623994

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
43353-312-104335303121010 CAPSULE in 1 BOTTLE (43353-312-10) 10 capsule2018-06-27NoNoCurrent
43353-312-154335303121515 CAPSULE in 1 BOTTLE (43353-312-15) 15 capsule2017-09-210000-00-00NoNoCurrent
43353-312-284335303122828 CAPSULE in 1 BOTTLE (43353-312-28) 28 capsule2018-06-27NoNoCurrent
43353-312-304335303123030 CAPSULE in 1 BOTTLE (43353-312-30) 30 capsule2017-05-010000-00-00NoNoCurrent
43353-312-454335303124545 CAPSULE in 1 BOTTLE (43353-312-45) 45 capsule2017-09-210000-00-00NoNoCurrent
43353-312-534335303125360 CAPSULE in 1 BOTTLE (43353-312-53) 60 capsule2017-05-010000-00-00NoNoCurrent
43353-312-604335303126090 CAPSULE in 1 BOTTLE (43353-312-60) 90 capsule2017-05-010000-00-00NoNoCurrent