FDA.reportPublic FDA data

Temazepam

Product NDC
80425-0295
11-digit product format
804250295
Labeler code
80425
Product ID
80425-0295_2a9ba8f4-6cec-e827-e063-6394a90a0300
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Temazepam
Dosage form
CAPSULE
Route
ORAL
Labeler
Advanced Rx Pharmacy of Tennessee, LLC
Application
ANDA071456
Marketing category
ANDA
Marketing start
2023-04-04
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
Rxcui198242

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
80425-0295-1Temazepam30 in 1 BOTTLECAPSULE302
80425-0295-2Temazepam60 in 1 BOTTLECAPSULE602
80425-0295-3Temazepam90 in 1 BOTTLECAPSULE902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0295-1EA - Each80425-029534ddee73-0dfb-422f-b27d-0e88531e071a12023-06-06
80425-0295-2EA - Each80425-0295ff7ce65a-7415-4125-92f4-dd67ef9f861512023-06-06
80425-0295-3EA - Each80425-0295e17e0465-1803-46d9-93ee-8d48486c8a3012023-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0295TEMAZEPAM CAPSULE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_f885bb1a-0445-c452-e053-6394a90ae8aa.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198242temazepam 30 MG Oral CapsulePSNf885bb1a-0445-c452-e053-6394a90ae8aa2
198242temazepam 30 MG Oral CapsuleSCDf885bb1a-0445-c452-e053-6394a90ae8aa2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
80425-0295-18042502950130 CAPSULE in 1 BOTTLE (80425-0295-1) 30 capsule2023-04-04NoNoHistorical
80425-0295-28042502950260 CAPSULE in 1 BOTTLE (80425-0295-2) 60 capsule2023-04-04NoNoHistorical
80425-0295-38042502950390 CAPSULE in 1 BOTTLE (80425-0295-3) 90 capsule2023-04-04NoNoHistorical