FDA.reportPublic FDA data

TEMAZEPAM

Product NDC
71610-625
11-digit product format
716100625
Labeler code
71610
Product ID
71610-625_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
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
71610-625-10TEMAZEPAM10 in 1 BOTTLECAPSULE104
71610-625-15TEMAZEPAM15 in 1 BOTTLECAPSULE154
71610-625-20TEMAZEPAM20 in 1 BOTTLECAPSULE204
71610-625-28TEMAZEPAM28 in 1 BOTTLECAPSULE284
71610-625-30TEMAZEPAM30 in 1 BOTTLECAPSULE304
71610-625-45TEMAZEPAM45 in 1 BOTTLECAPSULE454
71610-625-53TEMAZEPAM60 in 1 BOTTLECAPSULE604
71610-625-60TEMAZEPAM90 in 1 BOTTLECAPSULE904

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-625-10EA - Each71610-625bc3bd8d4-46d2-4057-9e10-ecdfb45932da12024-08-12
71610-625-15EA - Each71610-625367a9da9-b66d-4271-ac94-ac4ac0c199d712022-03-09
71610-625-20EA - Each71610-6254fea2df2-3549-412c-8a28-16c3ab2d060112024-08-12
71610-625-28EA - Each71610-625db3e87e4-9742-4e7e-ba29-1fb428d6f51612024-08-12
71610-625-30EA - Each71610-625f5146203-38dd-4ead-a803-fbf661d8cc5b12022-03-09
71610-625-45EA - Each71610-625e3b0f6cc-a04d-4afe-9746-52836d73f5f912022-03-09
71610-625-53EA - Each71610-62520aea86c-3cad-41f4-a426-d57ebb57c76412022-03-09
71610-625-60EA - Each71610-625dba1a9f6-e1b3-4eeb-aa3b-6599513e578f12022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-625TEMAZEPAM CAPSULE [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC ]4Current NDC, Legacy NDC, 8 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
71610-625-107161006251010 CAPSULE in 1 BOTTLE (71610-625-10) 10 capsule2024-06-14NoNoCurrent
71610-625-157161006251515 CAPSULE in 1 BOTTLE (71610-625-15) 15 capsule2021-12-100000-00-00NoNoCurrent
71610-625-207161006252020 CAPSULE in 1 BOTTLE (71610-625-20) 20 capsule2024-06-14NoNoCurrent
71610-625-287161006252828 CAPSULE in 1 BOTTLE (71610-625-28) 28 capsule2024-06-14NoNoCurrent
71610-625-307161006253030 CAPSULE in 1 BOTTLE (71610-625-30) 30 capsule2021-12-100000-00-00NoNoCurrent
71610-625-457161006254545 CAPSULE in 1 BOTTLE (71610-625-45) 45 capsule2021-12-100000-00-00NoNoCurrent
71610-625-537161006255360 CAPSULE in 1 BOTTLE (71610-625-53) 60 capsule2021-12-100000-00-00NoNoCurrent
71610-625-607161006256090 CAPSULE in 1 BOTTLE (71610-625-60) 90 capsule2021-12-100000-00-00NoNoCurrent